Amanda Rao
Research Subjects
Amanda Rao has a total of 46 co-authors. Here are the top co-authors by number of shared publications:
- David Briskey
RDC Clinical, Brisbane 4006, Australia
15 shared publications David Briskey
RDC Clinical
8 shared publications- Alistair Rowan Mallard
RDC Clinical, Brisbane, Australia
4 shared publications Paul Clayton
Department of Personalized and Preventive Medicine, Institute of Interdisciplinary Medicine, Moscow, Russia
3 shared publications- Chelsie Smith
RDC Clinical, Brisbane, QLD 4006, Australia
2 shared publications - Elizabeth Steels
School of Pharmacy, University of Queensland, Brisbane, QLD 4102, Australia
2 shared publications
Latest Publications
- Open Access
Targeted Colostrum Bioactive Proteins Improve Gastrointestinal Symptoms and Modulate the Gut Microbiome: A Randomised Double-Blind Placebo-Controlled Trial
Background: Gastrointestinal (GI) symptoms such as indigestion, bloating and reflux are common and can negatively affect quality of life. Bovine colostrum is a rich source of nutrients and other bioactive constituents that has been shown to be beneficial for gut health. Methods: This 12-week, randomised, double-blind, placebo-controlled, 3-arm study aimed to evaluate the effects of MaolactinGI™, a proprietary bovine colostrum supplement, on upper GI symptoms and gut microbiome composition in healthy adults aged 18 years and older experiencing moderate GI discomfort. Participants completed a 4-week run-in period followed by an 8-week intervention period. Outcomes measured included changes in upper GI symptoms via the Gastrointestinal Symptom Rating Scale (GSRS), Gastroesophageal Reflux Disease Questionnaire (GerdQ), Bloating Symptoms Visual Analogue Scale (BSVAS), Digestion-associated Quality of Life Questionnaire (DQLQ), Bristol Stool Chart, intestinal permeability, faecal calprotectin, serum inflammatory markers, gut microbiome analyses, blood safety markers and adverse events. Results: Ninety eligible participants were allocated to either the high-dose (500 mg/day), low-dose (250 mg/day), or placebo groups, and data from 83 participants were analysed. The high-dose MaolactinGI™ group demonstrated statistically significant improvements in the total GSRS score and DQLQ score compared with placebo, suggesting a meaningful reduction in total symptom burden and improved quality of life. The improvements in GSRS were clinically meaningful in size, supporting the practical relevance of MaolactinGI™ for adults experiencing everyday upper GI discomfort. High-dose supplementation also preserved microbial richness relative to placebo (Chao1); exploratory within-group analyses further indicated enrichment of SCFA-associated commensal taxa. The intervention was well tolerated and demonstrated an acceptable safety profile. Conclusions: These findings support the potential of targeted colostrum-derived bioactive protein fractions as a novel nutritional strategy for supporting GI health and microbiome balance.
Open AccessTargeted Colostrum Bioactive Proteins Improve Gastrointestinal Symptoms and Modulate the Gut Microbiome: A Randomised Double-Blind Placebo-Controlled Trial
Background: Gastrointestinal (GI) symptoms such as indigestion, bloating and reflux are common and can negatively affect quality of life. Bovine colostrum is a rich source of nutrients and other bioactive constituents that has been shown to be beneficial for gut health. Methods: This 12-week, randomised, double-blind, placebo-controlled, 3-arm study aimed to evaluate the effects of MaolactinGI™, a proprietary bovine colostrum supplement, on upper GI symptoms and gut microbiome composition in healthy adults aged 18 years and older experiencing moderate GI discomfort. Participants completed a 4-week run-in period followed by an 8-week intervention period. Outcomes measured included changes in upper GI symptoms via the Gastrointestinal Symptom Rating Scale (GSRS), Gastroesophageal Reflux Disease Questionnaire (GerdQ), Bloating Symptoms Visual Analogue Scale (BSVAS), Digestion-associated Quality of Life Questionnaire (DQLQ), Bristol Stool Chart, intestinal permeability, faecal calprotectin, serum inflammatory markers, gut microbiome analyses, blood safety markers and adverse events. Results: Ninety eligible participants were allocated to either the high-dose (500 mg/day), low-dose (250 mg/day), or placebo groups, and data from 83 participants were analysed. The high-dose MaolactinGI™ group demonstrated statistically significant improvements in the total GSRS score and DQLQ score compared with placebo, suggesting a meaningful reduction in total symptom burden and improved quality of life. The improvements in GSRS were clinically meaningful in size, supporting the practical relevance of MaolactinGI™ for adults experiencing everyday upper GI discomfort. High-dose supplementation also preserved microbial richness relative to placebo (Chao1); exploratory within-group analyses further indicated enrichment of SCFA-associated commensal taxa. The intervention was well tolerated and demonstrated an acceptable safety profile. Conclusions: These findings support the potential of targeted colostrum-derived bioactive protein fractions as a novel nutritional strategy for supporting GI health and microbiome balance.
- Open Access
- 13 October 2026
- Published by Frontiers Media SA in Frontiers in Nutrition
- Vol. 13, 1858064
Enhanced acute absorption of vitamin D3 with a liposomal formulation (Cymbiotika) compared to a standard formulation in healthy adults: a randomized double-blind crossover study
Background: Vitamin D deficiency is increasingly prevalent and linked to impaired health and disease. While vitamin D3 supplementation is effective, variability in absorption can influence bioavailability and clinical responses, with formulation characteristics potentially contributing to this variability. Method: The aim of this randomized, double-blind, crossover absorption study was to compare the absorption of a liposomal vitamin D3 formulation (Cymbiotika) with that of a conventional non-liposomal vitamin D3 formulation. Healthy adult participants received a single oral dose of both formulations in random order separated by a 2-week washout period. Blood samples were collected over 48 h post-dose and plasma cholecalciferol concentrations quantified. Absorption parameters including area under the concentration-time curve (AUC), maximum plasma concentration (Cmax), and time to peak concentration (Tmax) were calculated following baseline correction. Results: Twelve participants completed the study (mean age 34.3 ± 9.7 years; BMI 24.8 ± 2.7 kg/m2). The liposomal formulation showed greater systemic absorption compared with the comparator formulation, with a 1.9-fold higher AUC (199 vs. 106 ng·h/mL). Peak concentration was also higher for the liposomal formulation (8.4 vs. 6.0 ng/mL). Circulating cholecalciferol concentrations remained elevated above baseline at 48 h in the liposomal formulation but returned to baseline in the comparator formulation. Conclusion: These findings suggest that the Cymbiotika formulation may enhance the acute absorption of orally administered vitamin D3. Whether this enhanced acute absorption translates into improved long-term vitamin D status requires investigation in longer-term supplementation studies. Clinical trial registration: https://doi.org/10.1186/ISRCTN39055102 , identifier (ISRCTN39055102).
- 13 October 2026
- Published by Frontiers Media SA in Frontiers in Nutrition
- Vol. 13, 1858064
Open AccessEnhanced acute absorption of vitamin D3 with a liposomal formulation (Cymbiotika) compared to a standard formulation in healthy adults: a randomized double-blind crossover study
Background: Vitamin D deficiency is increasingly prevalent and linked to impaired health and disease. While vitamin D3 supplementation is effective, variability in absorption can influence bioavailability and clinical responses, with formulation characteristics potentially contributing to this variability. Method: The aim of this randomized, double-blind, crossover absorption study was to compare the absorption of a liposomal vitamin D3 formulation (Cymbiotika) with that of a conventional non-liposomal vitamin D3 formulation. Healthy adult participants received a single oral dose of both formulations in random order separated by a 2-week washout period. Blood samples were collected over 48 h post-dose and plasma cholecalciferol concentrations quantified. Absorption parameters including area under the concentration-time curve (AUC), maximum plasma concentration (Cmax), and time to peak concentration (Tmax) were calculated following baseline correction. Results: Twelve participants completed the study (mean age 34.3 ± 9.7 years; BMI 24.8 ± 2.7 kg/m2). The liposomal formulation showed greater systemic absorption compared with the comparator formulation, with a 1.9-fold higher AUC (199 vs. 106 ng·h/mL). Peak concentration was also higher for the liposomal formulation (8.4 vs. 6.0 ng/mL). Circulating cholecalciferol concentrations remained elevated above baseline at 48 h in the liposomal formulation but returned to baseline in the comparator formulation. Conclusion: These findings suggest that the Cymbiotika formulation may enhance the acute absorption of orally administered vitamin D3. Whether this enhanced acute absorption translates into improved long-term vitamin D status requires investigation in longer-term supplementation studies. Clinical trial registration: https://doi.org/10.1186/ISRCTN39055102 , identifier (ISRCTN39055102).
- Open Access
- 21 September 2026
- Published by Frontiers Media SA in Frontiers in Aging
- Vol. 7, 1858090
CaroRite™ for improving skin health and the visible signs of aging - a randomised, double-blind, placebo-controlled trial
Background: There is an increasing need to identify novel ingredients that can be safely utilized to enhance skin function and mitigate skin aging. Carotenoid supplementation shows promise in improving skin health and reducing signs of aging, owing to its antioxidant and anti-inflammatory properties. Aim: This randomised, double-blind, placebo-controlled study aimed to investigate the efficacy of a carotenoid supplement, CaroRite™, on skin health and the visible signs of aging in healthy females. Methods: Eighty female participants aged 40–55 years were recruited and randomised to receive either CaroRite™ (containing 28–30 mg mixed carotenoids) or a placebo. Participants were instructed to take one capsule daily for 12 weeks. Outcome measures included visible signs of aging (wrinkles, skin elasticity, hydration, sebum, pigmentation, pore size, and temperature), transepidermal water loss (TEWL), dermal thickness, skin carotenoid levels, dietary carotenoid intake, and safety. Results: No significant between-group differences were observed for visible signs of aging parameters (p > 0.05). At week 12, significant between-group differences from baseline were observed for TEWL (CaroRite™ −4.58 ± 9.43 vs. placebo 0.34 ± 6.73; p = 0.011) and dermal thickness (CaroRite™ 139.50 ± 220.21 μm vs. placebo 43.90 ± 225.97 μm; p = 0.036). Skin carotenoid levels increased by 48.1% in the active group (CaroRite™ +167.09 ± 117.23 vs. placebo 9.42 ± 47.16; p < 0.001), despite no significant differences in dietary carotenoid intake between groups. Conclusion: Daily oral supplementation with CaroRite™ did not reduce the visible signs of ageing after 12 weeks, however notable improvements in skin carotenoid status, TEWL and dermal thickness was found. CaroRite™ demonstrated good bioavailability and was well tolerated. Overall, these findings support the use of CaroRite™ as part of a comprehensive approach to potentially improving skin health, particularly for enhancing skin carotenoid status and supporting underlying structural and barrier function. Clinical Trial Registration: ClinicalTrials.gov , Identifier NCT06878001.
- 21 September 2026
- Published by Frontiers Media SA in Frontiers in Aging
- Vol. 7, 1858090
Open AccessCaroRite™ for improving skin health and the visible signs of aging - a randomised, double-blind, placebo-controlled trial
Background: There is an increasing need to identify novel ingredients that can be safely utilized to enhance skin function and mitigate skin aging. Carotenoid supplementation shows promise in improving skin health and reducing signs of aging, owing to its antioxidant and anti-inflammatory properties. Aim: This randomised, double-blind, placebo-controlled study aimed to investigate the efficacy of a carotenoid supplement, CaroRite™, on skin health and the visible signs of aging in healthy females. Methods: Eighty female participants aged 40–55 years were recruited and randomised to receive either CaroRite™ (containing 28–30 mg mixed carotenoids) or a placebo. Participants were instructed to take one capsule daily for 12 weeks. Outcome measures included visible signs of aging (wrinkles, skin elasticity, hydration, sebum, pigmentation, pore size, and temperature), transepidermal water loss (TEWL), dermal thickness, skin carotenoid levels, dietary carotenoid intake, and safety. Results: No significant between-group differences were observed for visible signs of aging parameters (p > 0.05). At week 12, significant between-group differences from baseline were observed for TEWL (CaroRite™ −4.58 ± 9.43 vs. placebo 0.34 ± 6.73; p = 0.011) and dermal thickness (CaroRite™ 139.50 ± 220.21 μm vs. placebo 43.90 ± 225.97 μm; p = 0.036). Skin carotenoid levels increased by 48.1% in the active group (CaroRite™ +167.09 ± 117.23 vs. placebo 9.42 ± 47.16; p < 0.001), despite no significant differences in dietary carotenoid intake between groups. Conclusion: Daily oral supplementation with CaroRite™ did not reduce the visible signs of ageing after 12 weeks, however notable improvements in skin carotenoid status, TEWL and dermal thickness was found. CaroRite™ demonstrated good bioavailability and was well tolerated. Overall, these findings support the use of CaroRite™ as part of a comprehensive approach to potentially improving skin health, particularly for enhancing skin carotenoid status and supporting underlying structural and barrier function. Clinical Trial Registration: ClinicalTrials.gov , Identifier NCT06878001.
- Open Access
- 15 July 2026
- Published by Frontiers Media SA in Frontiers in Endocrinology
- Vol. 17, 1879799
Acute TRPTI™ (oleoylethanolamide) supplementation enhances incretin hormone responses: a fixed-sequence crossover study
Background: Oleoylethanolamide (OEA) is an endogenous lipid mediator involved in nutrient sensing and gut-derived hormonal signalling. TRPTI™ is a bioavailable OEA formulation designed to support metabolic and appetite-related pathways. This study evaluated the acute metabolic effects of TRPTI™ in healthy adults under controlled feeding conditions. Methods: In this fixed-sequence, single-blind, placebo-controlled, three-period crossover study, 37 adults (BMI 25–34.9 kg/m²) received a single dose of a placebo, 150 mg TRPTI™, or 300 mg TRPTI™ following an overnight fast. Blood samples were collected over 8 hours, with standardised meals provided at 15 minutes and 4 hours post dose. Time-course responses of GLP-1, GIP, DPP-4, insulin, glucose, and glucagon were analysed. Results: Baseline adjusted GLP-1 and GIP AUC analyses demonstrated significant treatment effects across multiple pre-specified meal-related periods. The 300 mg TRPTI™ dose produced the greatest incretin responses and was significantly greater than placebo during selected pre-specified post-dosing and post-prandial periods, with elevations detectable within 15 minutes of ingestion. At key timepoints, GLP-1 concentrations were significantly higher (approximately 20–25%) than placebo. Similar significant increases were observed for GIP. Significant concentration changes in circulating DPP-4 were observed at later time points, indicating a potential association between TRPTI™ supplementation and serum DPP-4 modulation. Both TRPTI™ doses showed acute tolerability with safety biomarkers remaining within normal ranges. A statistically significant reduction in meal consumption was observed in both TRPTI™ groups. Conclusions: A single 300 mg dose of TRPTI™ enhances post-meal GLP-1 and GIP responses and demonstrates rapid engagement of GLP-1, GIP and DPP-4, supporting further investigation of its role in nutritional strategies targeting metabolic health. Clinical trial registration: https://clinicaltrials.gov/study/NCT06840080 , identifier NCT06840080.
- 15 July 2026
- Published by Frontiers Media SA in Frontiers in Endocrinology
- Vol. 17, 1879799
Open AccessAcute TRPTI™ (oleoylethanolamide) supplementation enhances incretin hormone responses: a fixed-sequence crossover study
Background: Oleoylethanolamide (OEA) is an endogenous lipid mediator involved in nutrient sensing and gut-derived hormonal signalling. TRPTI™ is a bioavailable OEA formulation designed to support metabolic and appetite-related pathways. This study evaluated the acute metabolic effects of TRPTI™ in healthy adults under controlled feeding conditions. Methods: In this fixed-sequence, single-blind, placebo-controlled, three-period crossover study, 37 adults (BMI 25–34.9 kg/m²) received a single dose of a placebo, 150 mg TRPTI™, or 300 mg TRPTI™ following an overnight fast. Blood samples were collected over 8 hours, with standardised meals provided at 15 minutes and 4 hours post dose. Time-course responses of GLP-1, GIP, DPP-4, insulin, glucose, and glucagon were analysed. Results: Baseline adjusted GLP-1 and GIP AUC analyses demonstrated significant treatment effects across multiple pre-specified meal-related periods. The 300 mg TRPTI™ dose produced the greatest incretin responses and was significantly greater than placebo during selected pre-specified post-dosing and post-prandial periods, with elevations detectable within 15 minutes of ingestion. At key timepoints, GLP-1 concentrations were significantly higher (approximately 20–25%) than placebo. Similar significant increases were observed for GIP. Significant concentration changes in circulating DPP-4 were observed at later time points, indicating a potential association between TRPTI™ supplementation and serum DPP-4 modulation. Both TRPTI™ doses showed acute tolerability with safety biomarkers remaining within normal ranges. A statistically significant reduction in meal consumption was observed in both TRPTI™ groups. Conclusions: A single 300 mg dose of TRPTI™ enhances post-meal GLP-1 and GIP responses and demonstrates rapid engagement of GLP-1, GIP and DPP-4, supporting further investigation of its role in nutritional strategies targeting metabolic health. Clinical trial registration: https://clinicaltrials.gov/study/NCT06840080 , identifier NCT06840080.
- Open Access
- 13 February 2026
- Published by Frontiers Media SA in Frontiers in Veterinary Science
- Vol. 13, 1703143
Levagen+ (palmitoylethanolamide) alleviates joint pain and reduces the impact of joint pain in canines and felines: a double-blind, placebo-controlled, randomized clinical trial
Introduction: This study assessed the effectiveness of Levagen+ (palmitoylethanolamide), a fatty acid amide and lipid mediator, for both the alleviation and impact of joint pain, in canines and felines. Methods: This prospective double-blinded, randomized placebo-controlled study supplemented 50 canines and 50 felines experiencing joint pain daily for 6 weeks with either Levagen+ or a placebo taken orally. Efficacy was determined in canines using the Canine Brief Pain Index (CBPI) and in felines using the Feline Musculoskeletal Pain Index (FMPI), both completed by owners at baseline, week 2, week 4 and week 6. Data were analyzed with distribution-appropriate tests and a two-way repeated-measures ANOVA to assess group, time, and interaction effects across outcomes. Results: In canines, significantly more were classified as successfully treated in the Levagen+ group compared to the placebo group (76% vs. 40%; p < 0.05), with significant improvements in multiple pain and functional interference domains. In felines, significant between-group differences were observed for specific functional tasks [jumping up ( p < 0.05), jumping down ( p < 0.05)] and in scores for current pain [week 2 ( p < 0.05) and week 6 ( p < 0.05)]. Levagen+ was well tolerated in both species. Discussion: These findings supported the hypothesis that Levagen+ reduces the impact of joint pain in companion animals.
- 13 February 2026
- Published by Frontiers Media SA in Frontiers in Veterinary Science
- Vol. 13, 1703143
Open AccessLevagen+ (palmitoylethanolamide) alleviates joint pain and reduces the impact of joint pain in canines and felines: a double-blind, placebo-controlled, randomized clinical trial
Introduction: This study assessed the effectiveness of Levagen+ (palmitoylethanolamide), a fatty acid amide and lipid mediator, for both the alleviation and impact of joint pain, in canines and felines. Methods: This prospective double-blinded, randomized placebo-controlled study supplemented 50 canines and 50 felines experiencing joint pain daily for 6 weeks with either Levagen+ or a placebo taken orally. Efficacy was determined in canines using the Canine Brief Pain Index (CBPI) and in felines using the Feline Musculoskeletal Pain Index (FMPI), both completed by owners at baseline, week 2, week 4 and week 6. Data were analyzed with distribution-appropriate tests and a two-way repeated-measures ANOVA to assess group, time, and interaction effects across outcomes. Results: In canines, significantly more were classified as successfully treated in the Levagen+ group compared to the placebo group (76% vs. 40%; p < 0.05), with significant improvements in multiple pain and functional interference domains. In felines, significant between-group differences were observed for specific functional tasks [jumping up ( p < 0.05), jumping down ( p < 0.05)] and in scores for current pain [week 2 ( p < 0.05) and week 6 ( p < 0.05)]. Levagen+ was well tolerated in both species. Discussion: These findings supported the hypothesis that Levagen+ reduces the impact of joint pain in companion animals.
- Open Access
- 3 November 2025
- Published by MDPI AG in Nutraceuticals
- Vol. 5 (4) , 35
Effect of Ageratum Conyzoides on Osteoarthritis in an Ageing Adult Population: A Double-Blind Randomized Placebo-Controlled Parallel Study
This randomized, double-blind, placebo-controlled study investigated Ageratum conyzoides (A. conyzoides) for alleviating osteoarthritis symptoms and improving quality of life. Conducted in Australia between 2021 and 2024, the study included 70 adults aged ≥45 years with clinically diagnosed osteoarthritis. Participants consumed 250 mg of pyrrolizidine alkaloid-free A. conyzoides extract or a placebo daily for 12 weeks. Pain and function were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) every three weeks. Secondary measures included pain assessed by the Visual Analogue Scale (VAS), the SF-36 quality-of-life questionnaire, inflammatory markers, and safety parameters. A. conyzoides supplementation resulted in significant reductions in total WOMAC scores at weeks 9 and 12 (p < 0.05) compared to placebo. VAS pain scores were significantly lower at weeks 9 and 12 (p < 0.05). SF-36 scores improved significantly in the pain and role limitations due to physical health domains (p < 0.05). Plasma inflammatory markers IL-6 and IL-8 showed significant reductions compared with placebo (p < 0.05). No between-group differences were observed for adverse events. These findings demonstrate that A. conyzoides supplementation is a safe and effective option for reducing osteoarthritis symptoms, with significant improvements observed in pain, function, and inflammatory markers.
- 3 November 2025
- Published by MDPI AG in Nutraceuticals
- Vol. 5 (4) , 35
Open AccessEffect of Ageratum Conyzoides on Osteoarthritis in an Ageing Adult Population: A Double-Blind Randomized Placebo-Controlled Parallel Study
This randomized, double-blind, placebo-controlled study investigated Ageratum conyzoides (A. conyzoides) for alleviating osteoarthritis symptoms and improving quality of life. Conducted in Australia between 2021 and 2024, the study included 70 adults aged ≥45 years with clinically diagnosed osteoarthritis. Participants consumed 250 mg of pyrrolizidine alkaloid-free A. conyzoides extract or a placebo daily for 12 weeks. Pain and function were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) every three weeks. Secondary measures included pain assessed by the Visual Analogue Scale (VAS), the SF-36 quality-of-life questionnaire, inflammatory markers, and safety parameters. A. conyzoides supplementation resulted in significant reductions in total WOMAC scores at weeks 9 and 12 (p < 0.05) compared to placebo. VAS pain scores were significantly lower at weeks 9 and 12 (p < 0.05). SF-36 scores improved significantly in the pain and role limitations due to physical health domains (p < 0.05). Plasma inflammatory markers IL-6 and IL-8 showed significant reductions compared with placebo (p < 0.05). No between-group differences were observed for adverse events. These findings demonstrate that A. conyzoides supplementation is a safe and effective option for reducing osteoarthritis symptoms, with significant improvements observed in pain, function, and inflammatory markers.
- Open Access
- 8 July 2025
- Published by Herald Scholarly Open Access in Journal of Alternative, Complementary & Integrative Medicine
- Vol. 11 (6) , 1-7
The Effect of Topical Palmitoylethanolamide (PlexoZome Levagen) on Relief of Post Exercise Knee Joint Pain – A Randomised Double-Blind Controlled Study
Joint pain is a common ailment that can arise from several different causes and may affect people of any age. It can negatively impact quality of life and represents a significant global health concern
- 8 July 2025
- Published by Herald Scholarly Open Access in Journal of Alternative, Complementary & Integrative Medicine
- Vol. 11 (6) , 1-7
Open AccessThe Effect of Topical Palmitoylethanolamide (PlexoZome Levagen) on Relief of Post Exercise Knee Joint Pain – A Randomised Double-Blind Controlled Study
Joint pain is a common ailment that can arise from several different causes and may affect people of any age. It can negatively impact quality of life and represents a significant global health concern
- Open Access
- 20 July 2024
- Published by MDPI AG in Biomedicines
- Vol. 12 (7) , 1620
Effect of Palmitoylethanolamide Compared to a Placebo on the Gut Microbiome and Biochemistry in an Overweight Adult Population: A Randomised, Placebo Controlled, Double-Blind Study
This study investigates the effects of palmitoylethanolamide (PEA) on the gut microbiome of overweight adults. Fifty-eight participants (twenty males, thirty-eight females) aged 18–65 years with a BMI range of 30–40 kg/m2 were recruited. Participants were randomised to receive PEA (n = 36) or a placebo (n = 22) for 12 weeks. Microbiota composition, richness, diversity, and metabolic functions, faecal short chain fatty acids and calprotectin, pathology markers, and health-related questionnaires were analysed throughout the 12 weeks of supplementation. PEA supplementation significantly reduced triglyceride levels and IL-2 concentrations. No significant differences were found in the overall microbiota composition between the groups, and microbiota richness and diversity remained consistent for both groups. Functional analysis demonstrated no differences in functional richness and diversity, but specific pathways were modified. PEA supplementation resulted in a decrease in the abundance of pathways related to aromatic compound degradation, NAD interconversion, and L-glutamate degradation, while pathways associated with molybdopterin biosynthesis and O-antigen building blocks exhibited increased abundance. Increased production of O-antigen results in smooth LPS associated with reduced pathogenic stealth and persistence. PEA supplementation may influence specific microbial species, metabolic pathways, and reduce serum triglyceride and IL-2 concentration, shedding light on the intricate relationship between PEA, the microbiome, and host health.
- 20 July 2024
- Published by MDPI AG in Biomedicines
- Vol. 12 (7) , 1620
Open AccessEffect of Palmitoylethanolamide Compared to a Placebo on the Gut Microbiome and Biochemistry in an Overweight Adult Population: A Randomised, Placebo Controlled, Double-Blind Study
This study investigates the effects of palmitoylethanolamide (PEA) on the gut microbiome of overweight adults. Fifty-eight participants (twenty males, thirty-eight females) aged 18–65 years with a BMI range of 30–40 kg/m2 were recruited. Participants were randomised to receive PEA (n = 36) or a placebo (n = 22) for 12 weeks. Microbiota composition, richness, diversity, and metabolic functions, faecal short chain fatty acids and calprotectin, pathology markers, and health-related questionnaires were analysed throughout the 12 weeks of supplementation. PEA supplementation significantly reduced triglyceride levels and IL-2 concentrations. No significant differences were found in the overall microbiota composition between the groups, and microbiota richness and diversity remained consistent for both groups. Functional analysis demonstrated no differences in functional richness and diversity, but specific pathways were modified. PEA supplementation resulted in a decrease in the abundance of pathways related to aromatic compound degradation, NAD interconversion, and L-glutamate degradation, while pathways associated with molybdopterin biosynthesis and O-antigen building blocks exhibited increased abundance. Increased production of O-antigen results in smooth LPS associated with reduced pathogenic stealth and persistence. PEA supplementation may influence specific microbial species, metabolic pathways, and reduce serum triglyceride and IL-2 concentration, shedding light on the intricate relationship between PEA, the microbiome, and host health.
- Open Access
- 17 June 2024
- Published by Spandidos Publications in International Journal of Functional Nutrition
- Vol. 5 (1) , 1-7
Comparison of the effects of Wild Nutrition Food‑Grown® vitamin D3 formulation with two conventional formulations on increasing plasma vitamin D levels in healthy participants: A 72‑h, randomised, parallel, comparator study
Vitamin D is a fat‑soluble hormone involved in numerous vital physiological functions. Despite the critical role of vitamin D, a large proportion of the population are deficient (max) and maximum change from baseline (Cmax) calculated. All three group demographics were equal at baseline. The Food‑Grown® vitamin D group exhibited a significant increase in total vitamin D absorption (AUC, 156.2±54.6 vs. 105.0±44.8) over the 72‑h period compared to the conventional tablet formulation. The Cmax and Tmax did not differ significantly between the groups. On the whole, these results indicate that a Food‑Grown® vitamin D formulation is superior to conventional vitamin D tablets and equivalent to a buccal spray.
- 17 June 2024
- Published by Spandidos Publications in International Journal of Functional Nutrition
- Vol. 5 (1) , 1-7
Open AccessComparison of the effects of Wild Nutrition Food‑Grown® vitamin D3 formulation with two conventional formulations on increasing plasma vitamin D levels in healthy participants: A 72‑h, randomised, parallel, comparator study
Vitamin D is a fat‑soluble hormone involved in numerous vital physiological functions. Despite the critical role of vitamin D, a large proportion of the population are deficient (max) and maximum change from baseline (Cmax) calculated. All three group demographics were equal at baseline. The Food‑Grown® vitamin D group exhibited a significant increase in total vitamin D absorption (AUC, 156.2±54.6 vs. 105.0±44.8) over the 72‑h period compared to the conventional tablet formulation. The Cmax and Tmax did not differ significantly between the groups. On the whole, these results indicate that a Food‑Grown® vitamin D formulation is superior to conventional vitamin D tablets and equivalent to a buccal spray.
- Open Access
- 23 January 2024
- Published by MDPI AG in Pharmaceuticals
- Vol. 17 (2) , 145
Effectiveness of Palmitoylethanolamide (Levagen+) Compared to a Placebo for Reducing Pain, Duration, and Medication Use during Migraines in Otherwise Healthy Participants—A Double-Blind Randomised Controlled Study
Migraines are a common neurological disorder that generally affects young to middle-aged adults and females more than males. Various treatment options are available; however, these can cause undesirable side effects. Therefore, alternative treatments with minimal side effects are still being investigated. Palmitoylethanolamide (PEA) is a signalling lipid known to have anti-inflammatory and analgesic properties. Previous prophylactic research has reported PEA supplementation to decrease pain associated with migraines. Upon commencement of migraine symptoms, participants were supplemented with either 600 mg of PEA (Levagen+) or a placebo (maltodextrin). Once a dose was taken, participants recorded a visual analogue scale (VAS) for pain every 30 min for 4 h or until the migraine resolved. If the migraine had not resolved 2 h post-dose, participants were instructed to take a second dose. Levagen+ supplementation resolved more headaches after 2- and 8 h, had a lower VAS for pain score at 1.5 and 4 h, and reduced rescue medication use significantly more than a placebo. No adverse events were reported in either group. Overall, PEA was safe and effective in reducing migraine pain, duration, and medication use in an otherwise healthy adult population.
- 23 January 2024
- Published by MDPI AG in Pharmaceuticals
- Vol. 17 (2) , 145
Open AccessEffectiveness of Palmitoylethanolamide (Levagen+) Compared to a Placebo for Reducing Pain, Duration, and Medication Use during Migraines in Otherwise Healthy Participants—A Double-Blind Randomised Controlled Study
Migraines are a common neurological disorder that generally affects young to middle-aged adults and females more than males. Various treatment options are available; however, these can cause undesirable side effects. Therefore, alternative treatments with minimal side effects are still being investigated. Palmitoylethanolamide (PEA) is a signalling lipid known to have anti-inflammatory and analgesic properties. Previous prophylactic research has reported PEA supplementation to decrease pain associated with migraines. Upon commencement of migraine symptoms, participants were supplemented with either 600 mg of PEA (Levagen+) or a placebo (maltodextrin). Once a dose was taken, participants recorded a visual analogue scale (VAS) for pain every 30 min for 4 h or until the migraine resolved. If the migraine had not resolved 2 h post-dose, participants were instructed to take a second dose. Levagen+ supplementation resolved more headaches after 2- and 8 h, had a lower VAS for pain score at 1.5 and 4 h, and reduced rescue medication use significantly more than a placebo. No adverse events were reported in either group. Overall, PEA was safe and effective in reducing migraine pain, duration, and medication use in an otherwise healthy adult population.