Nágila Raquel Teixeira Damasceno
Current Organizations / Institutes
The organizations/institutes from the scholar's latest article
Research Subjects
Nágila Raquel Teixeira Damasceno has a total of 304 co-authors. Here are the top co-authors by number of shared publications:
- Antonio Martins Figueiredo Neto
Institute of Physics, University of São Paulo, São Paulo, Brazil
9 shared publications - Maria Camila Pruper de Freitas
Department of Nutrition, Faculty of Public Health, University of Sao Paulo, Av. Dr. Arnaldo, 715, 01246-904, Sao Paulo, SP, Brazil
7 shared publications - Ana Paula de Queiroz Mello
Centro Universitário São Camilo
5 shared publications - Antonio Augusto Ferreira Carioca
Universidade de Fortaleza, Brazil
4 shared publications - Ernani Tiaraju de Santa Helena
Universidade Regional de Blumenau
4 shared publications - Marcello Ricardo Paulista Markus
German Centre for Cardiovascular Research (DZHK), partner site North, Greifswald, Germany
4 shared publications
Latest Publications
- Open Access
- 18 September 2026
- Published by Universidade de São Paulo. Agência de Bibliotecas e Coleções Digitais
Na cozinha da escola: orientações e boas práticas para necessidades alimentares especiais
Este e-book nasce da necessidade de apoiar, de forma clara e fundamentada, os profissionais que atuam diretamente na alimentação escolar. Mais do que um conjunto de orientações técnicas, este material representa um instrumento de cuidado, responsabilidade e valorização do trabalho de cozinheiras, nutricionistas e demais profissionais envolvidos nesse processo. Ao longo das páginas, o leitor encontrará uma abordagem que integra conhecimento científico e aplicação prática. São apresentados os principais conceitos relacionados às Necessidades Alimentares Especiais (NAE), seguidos de diretrizes objetivas que orientam o preparo seguro dos alimentos, a prevenção de riscos e a organização dos serviços de alimentação nas escolas. Essa estrutura busca não apenas informar, mas também fortalecer a autonomia e a segurança das equipes no cotidiano. É importante reconhecer que cada estudante é único, e que o cuidado com a alimentação vai além da nutrição: envolve acolhimento, respeito e inclusão. Assim, este material convida todos os profissionais da comunidade escolar a refletirem sobre seu papel nesse processo e a atuarem de forma integrada, consciente e comprometida, porque garantir uma alimentação segura não é apenas uma exigência legal, é um ato de cuidado que transforma vidas.
- 18 September 2026
- Published by Universidade de São Paulo. Agência de Bibliotecas e Coleções Digitais
Open AccessNa cozinha da escola: orientações e boas práticas para necessidades alimentares especiais
Este e-book nasce da necessidade de apoiar, de forma clara e fundamentada, os profissionais que atuam diretamente na alimentação escolar. Mais do que um conjunto de orientações técnicas, este material representa um instrumento de cuidado, responsabilidade e valorização do trabalho de cozinheiras, nutricionistas e demais profissionais envolvidos nesse processo. Ao longo das páginas, o leitor encontrará uma abordagem que integra conhecimento científico e aplicação prática. São apresentados os principais conceitos relacionados às Necessidades Alimentares Especiais (NAE), seguidos de diretrizes objetivas que orientam o preparo seguro dos alimentos, a prevenção de riscos e a organização dos serviços de alimentação nas escolas. Essa estrutura busca não apenas informar, mas também fortalecer a autonomia e a segurança das equipes no cotidiano. É importante reconhecer que cada estudante é único, e que o cuidado com a alimentação vai além da nutrição: envolve acolhimento, respeito e inclusão. Assim, este material convida todos os profissionais da comunidade escolar a refletirem sobre seu papel nesse processo e a atuarem de forma integrada, consciente e comprometida, porque garantir uma alimentação segura não é apenas uma exigência legal, é um ato de cuidado que transforma vidas.
- Open Access
- 23 March 2026
- Published by Springer Nature in Inflammation
- Vol. 49 (1)
Long-Term Fructose Intake Induces Moderate Liver Inflammation but Does not Overlap with the Detrimental Effects of the Ketogenic Diet on Hepatic Steatosis in Rats
An excess of fat and carbohydrate exerts a negative role on liver metabolism, favouring the development of metabolic dysfunction-associated steatotic liver disease (MASLD). However, it is not clear which component of the diet is more detrimental to liver homeostasis. We assessed the long-term effect of high fructose and the ketogenic diet on hepatic steatosis. For this purpose, 18 adult male Wistar rats were randomized into three groups: Control Diet (CD), consisting of commercial chow; Fructose Diet (FD), which included commercial chow and water with 30% fructose; and Ketogenic Diet (KD), comprising high-fat chow (90% fat). Chow and water intake were provided ad libitum during the 100-day follow-up period. Despite the differences in calorie intake, animals exhibited similar weight gain and body length, except for the KD group at T5. Ketosis was achieved in the KD group, while glucose and fructose remained unchanged in all groups. KD promoted increases in liver enzymes (AST, ALT, GGT, and ALP) and simultaneous lipid infiltration, characterized by high TC, TG, and NEFA levels. Advanced oxidized lipids (TBARS) were reduced. Long-term FD intake stimulated inflammatory pathways, as indicated by elevated levels of IL-1β, IL-6, IL-10, and TNF-α, compared to the CD and KD groups. Although relative liver weight was high in FD, the direct evaluation of total fat confirmed the high lipid infiltration in the KD group. Histological analysis of the liver tissue revealed a marked inflammatory infiltrate of macrophages and hepatic steatosis in the KD group. In conclusion, long-term KD intervention promoted hepatic steatosis through dysfunction in lipid metabolism and inflammation, while FD induced a more pronounced inflammatory response.
- 23 March 2026
- Published by Springer Nature in Inflammation
- Vol. 49 (1)
Open AccessLong-Term Fructose Intake Induces Moderate Liver Inflammation but Does not Overlap with the Detrimental Effects of the Ketogenic Diet on Hepatic Steatosis in Rats
An excess of fat and carbohydrate exerts a negative role on liver metabolism, favouring the development of metabolic dysfunction-associated steatotic liver disease (MASLD). However, it is not clear which component of the diet is more detrimental to liver homeostasis. We assessed the long-term effect of high fructose and the ketogenic diet on hepatic steatosis. For this purpose, 18 adult male Wistar rats were randomized into three groups: Control Diet (CD), consisting of commercial chow; Fructose Diet (FD), which included commercial chow and water with 30% fructose; and Ketogenic Diet (KD), comprising high-fat chow (90% fat). Chow and water intake were provided ad libitum during the 100-day follow-up period. Despite the differences in calorie intake, animals exhibited similar weight gain and body length, except for the KD group at T5. Ketosis was achieved in the KD group, while glucose and fructose remained unchanged in all groups. KD promoted increases in liver enzymes (AST, ALT, GGT, and ALP) and simultaneous lipid infiltration, characterized by high TC, TG, and NEFA levels. Advanced oxidized lipids (TBARS) were reduced. Long-term FD intake stimulated inflammatory pathways, as indicated by elevated levels of IL-1β, IL-6, IL-10, and TNF-α, compared to the CD and KD groups. Although relative liver weight was high in FD, the direct evaluation of total fat confirmed the high lipid infiltration in the KD group. Histological analysis of the liver tissue revealed a marked inflammatory infiltrate of macrophages and hepatic steatosis in the KD group. In conclusion, long-term KD intervention promoted hepatic steatosis through dysfunction in lipid metabolism and inflammation, while FD induced a more pronounced inflammatory response.
- 13 January 2026
- Published by Elsevier in Journal of Clinical Lipidology
- Vol. 20 (3) , 529-540
Exploratory genome-wide analysis suggests potential associations of PPP1R12B, FSTL5, G5K3B, and GFRA2 loci with a derived HDL functionality score
- 13 January 2026
- Published by Elsevier in Journal of Clinical Lipidology
- Vol. 20 (3) , 529-540
Exploratory genome-wide analysis suggests potential associations of PPP1R12B, FSTL5, G5K3B, and GFRA2 loci with a derived HDL functionality score
- Open Access
- 2 January 2026
- Published by Instituto para o Desenvolvimento da Educacao in Journal of Health & Biological Sciences
- Vol. 14 (1) , e6395
Influência do polimorfismo de nucleotídio único do gene apoa1 (rs670) no tamanho e na ação antioxidante da HDL
Objetivo: avaliar o envolvimento do polimorfismo de nucleotídeo único (SNP) rs670 no tamanho das partículas e na ação antioxidante do HDL. Métodos: foram coletados dados socioeconômicos, sociodemográficos e clínicos. Além disso, foram determinados dados antropométricos, perfis glicêmicos e lipídicos, níveis de apolipoproteína A-I e B, níveis de ácidos graxos não esterificados, índice ômega-3, genotipagem do SNP rs670 e subfrações de partículas de HDL e função antioxidante. Resultados: 78 indivíduos, com prevalência de mulheres (46, 59%), idade média de 40 (±14) anos, presença de fatores de risco cardiovascular (n = 72; 92,3%), entre outros. De acordo com o SNP rs670, não foi observada diferença entre os parâmetros sociodemográficos, glicolipídicos, antropométricos e capacidade antioxidante da HDL. No entanto, o genótipo CC mostrou correlações entre o colesterol HDL e a glicemia(rho=-0,304), triglicerídeos (rho=-0,324), índice de massa corporal (rho=-0,439) e circunferência da cintura (rho=-0,516). Os genótipos CT e TT mostraram correlações entre a relação HDL 1-2/9-10 e a glicemia (rho=-0,576) e a relação Apo B/Apo A-I (rho=-0,629). Além disso, a presença do alelo T pode ser prevista pela relação HDL 1-2/9-10. Conclusões: conclui-se que o alelo T polimórfico estava associado a relações HDL mais elevadas em relação às mais baixas, possivelmente afetando sua funcionalidade.
- 2 January 2026
- Published by Instituto para o Desenvolvimento da Educacao in Journal of Health & Biological Sciences
- Vol. 14 (1) , e6395
Open AccessInfluência do polimorfismo de nucleotídio único do gene apoa1 (rs670) no tamanho e na ação antioxidante da HDL
Objetivo: avaliar o envolvimento do polimorfismo de nucleotídeo único (SNP) rs670 no tamanho das partículas e na ação antioxidante do HDL. Métodos: foram coletados dados socioeconômicos, sociodemográficos e clínicos. Além disso, foram determinados dados antropométricos, perfis glicêmicos e lipídicos, níveis de apolipoproteína A-I e B, níveis de ácidos graxos não esterificados, índice ômega-3, genotipagem do SNP rs670 e subfrações de partículas de HDL e função antioxidante. Resultados: 78 indivíduos, com prevalência de mulheres (46, 59%), idade média de 40 (±14) anos, presença de fatores de risco cardiovascular (n = 72; 92,3%), entre outros. De acordo com o SNP rs670, não foi observada diferença entre os parâmetros sociodemográficos, glicolipídicos, antropométricos e capacidade antioxidante da HDL. No entanto, o genótipo CC mostrou correlações entre o colesterol HDL e a glicemia(rho=-0,304), triglicerídeos (rho=-0,324), índice de massa corporal (rho=-0,439) e circunferência da cintura (rho=-0,516). Os genótipos CT e TT mostraram correlações entre a relação HDL 1-2/9-10 e a glicemia (rho=-0,576) e a relação Apo B/Apo A-I (rho=-0,629). Além disso, a presença do alelo T pode ser prevista pela relação HDL 1-2/9-10. Conclusões: conclui-se que o alelo T polimórfico estava associado a relações HDL mais elevadas em relação às mais baixas, possivelmente afetando sua funcionalidade.
- Open Access
- 1 January 2026
- Published by Springer Nature in Molecular Neurobiology
- Vol. 63 (1)
Influence of Ketogenic Diet Lipid Composition on Anxiety-Like Behavior and Neurometabolic Profile in Healthy Rats
Ketogenic diets (KDs) modulate brain function, but how their fatty acid composition impacts behavior remains poorly understood. Male Wistar rats were fed a control diet (CD, n = 6), a classic ketogenic diet (CKD, n = 6) rich in saturated fatty acids (SAFAs), or a modified ketogenic diet (MKD, n = 6) enriched with polyunsaturated fatty acids (PUFAs) and DHA. After 100 days, both KDs induced similar ketosis and increased brain glucose metabolism ( 1 ⁸F-FDG PET/CT), while reducing some cerebral pro-inflammatory cytokines (IL-1β, IL-6) and oxidized LDL. Notably, the CKD group exhibited an anxiety-like phenotype in the Elevated Plus Maze versus controls, significantly reducing open arm entries [1.58(0.60) vs. 5.08(1.03); p = 0.025], increasing closed arm time [3.33 min(0.22) vs. 1.70 min(0.19); p = 0.001], and elevating the Anxiety Index [0.92(0.04) vs. 0.70(0.07); p = 0.048], which correlated with SAFA incorporation in the frontal lobe. In contrast, the MKD group did not induce this anxiety-like effect, maintaining behavioral parameters comparable to the CD group, while showing an intense incorporation of omega-3 fatty acids and DHA in the hippocampus. These findings demonstrate that the behavioral divergence between KDs occurred despite shared reductions in the specific neuroinflammatory and oxidative markers evaluated. Overall, our results suggest that the dietary fatty acid profile, rather than the magnitude of systemic ketosis level, plays a critical role in modulating behavioral outcomes under ketogenic conditions.
- 1 January 2026
- Published by Springer Nature in Molecular Neurobiology
- Vol. 63 (1)
Open AccessInfluence of Ketogenic Diet Lipid Composition on Anxiety-Like Behavior and Neurometabolic Profile in Healthy Rats
Ketogenic diets (KDs) modulate brain function, but how their fatty acid composition impacts behavior remains poorly understood. Male Wistar rats were fed a control diet (CD, n = 6), a classic ketogenic diet (CKD, n = 6) rich in saturated fatty acids (SAFAs), or a modified ketogenic diet (MKD, n = 6) enriched with polyunsaturated fatty acids (PUFAs) and DHA. After 100 days, both KDs induced similar ketosis and increased brain glucose metabolism ( 1 ⁸F-FDG PET/CT), while reducing some cerebral pro-inflammatory cytokines (IL-1β, IL-6) and oxidized LDL. Notably, the CKD group exhibited an anxiety-like phenotype in the Elevated Plus Maze versus controls, significantly reducing open arm entries [1.58(0.60) vs. 5.08(1.03); p = 0.025], increasing closed arm time [3.33 min(0.22) vs. 1.70 min(0.19); p = 0.001], and elevating the Anxiety Index [0.92(0.04) vs. 0.70(0.07); p = 0.048], which correlated with SAFA incorporation in the frontal lobe. In contrast, the MKD group did not induce this anxiety-like effect, maintaining behavioral parameters comparable to the CD group, while showing an intense incorporation of omega-3 fatty acids and DHA in the hippocampus. These findings demonstrate that the behavioral divergence between KDs occurred despite shared reductions in the specific neuroinflammatory and oxidative markers evaluated. Overall, our results suggest that the dietary fatty acid profile, rather than the magnitude of systemic ketosis level, plays a critical role in modulating behavioral outcomes under ketogenic conditions.
- 25 November 2025
- Published by Elsevier in Journal of Clinical Lipidology
- Vol. 20 (2) , 378-388
Metabolic and functional aspects of high-density lipoproteins (HDL) in familial hypercholesterolemia with or without subclinical coronary atherosclerosis
- 25 November 2025
- Published by Elsevier in Journal of Clinical Lipidology
- Vol. 20 (2) , 378-388
Metabolic and functional aspects of high-density lipoproteins (HDL) in familial hypercholesterolemia with or without subclinical coronary atherosclerosis
- Open Access
Associations of Omega-3 and Omega-6 Fatty Acids Intake with Visceral Adiposity: Sex-Specific Patterns in a Population-Based Study
Background: Obesity is a disease with high prevalence worldwide, and the accumulation of visceral fat is related to increased cardiovascular risk. The inclusion of polyunsaturated fatty acids (PUFAs) in the diet has been shown to be a promising nutritional strategy. We aimed to examine the associations between PUFAs consumption and visceral adiposity dysfunction, assessed by the visceral adiposity index (VAI). Methods: This cross-sectional study included 697 adults from the SHIP-Brazil cohort. Structured interviews collected sociodemographic, lifestyle, and dietary data. The intake of omega-3, omega-6, EPA, DHA, and EPA + DHA intake assessed through an adapted food frequency questionnaire (FFQ) was categorized into tertiles. Serum lipids were analyzed using the Cobas system, and VAI was calculated by a sex-specific formula and categorized into two groups (low and high VAI, p50), according to sex. Results: Among men, a higher VAI was associated with greater energy intake and higher carbohydrate and fat consumption. Among women, EPA + DHA intake (β = −0.396, 95% CI: −0.639; −0.152, p = 0.001), EPA (β = −0.679, 95% CI: −1.220; −0.138, p = 0.014), and DHA (β = −0.780, 95% CI: −1.207; −0.352, p < 0.001) were negatively associated with VAI, while omega-6 (β = 0.015, 95% CI: 0.003; 0.028, p = 0.017) showed a positive association. No associations were found between saturated and monounsaturated fatty acids and VAI. Conclusions: The EPA + DHA intake, EPA, and DHA intake were inversely associated with VAI in women, but not in men. Omega-6 intake was negatively associated with VAI in men and positively associated with VAI in women. It is important to highlight that, given the cross-sectional design, these associations do not establish temporality or causality.
Open AccessAssociations of Omega-3 and Omega-6 Fatty Acids Intake with Visceral Adiposity: Sex-Specific Patterns in a Population-Based Study
Background: Obesity is a disease with high prevalence worldwide, and the accumulation of visceral fat is related to increased cardiovascular risk. The inclusion of polyunsaturated fatty acids (PUFAs) in the diet has been shown to be a promising nutritional strategy. We aimed to examine the associations between PUFAs consumption and visceral adiposity dysfunction, assessed by the visceral adiposity index (VAI). Methods: This cross-sectional study included 697 adults from the SHIP-Brazil cohort. Structured interviews collected sociodemographic, lifestyle, and dietary data. The intake of omega-3, omega-6, EPA, DHA, and EPA + DHA intake assessed through an adapted food frequency questionnaire (FFQ) was categorized into tertiles. Serum lipids were analyzed using the Cobas system, and VAI was calculated by a sex-specific formula and categorized into two groups (low and high VAI, p50), according to sex. Results: Among men, a higher VAI was associated with greater energy intake and higher carbohydrate and fat consumption. Among women, EPA + DHA intake (β = −0.396, 95% CI: −0.639; −0.152, p = 0.001), EPA (β = −0.679, 95% CI: −1.220; −0.138, p = 0.014), and DHA (β = −0.780, 95% CI: −1.207; −0.352, p < 0.001) were negatively associated with VAI, while omega-6 (β = 0.015, 95% CI: 0.003; 0.028, p = 0.017) showed a positive association. No associations were found between saturated and monounsaturated fatty acids and VAI. Conclusions: The EPA + DHA intake, EPA, and DHA intake were inversely associated with VAI in women, but not in men. Omega-6 intake was negatively associated with VAI in men and positively associated with VAI in women. It is important to highlight that, given the cross-sectional design, these associations do not establish temporality or causality.
- 15 October 2025
- Published by Elsevier in Clinical Nutrition ESPEN
- Vol. 70, 360-372
Plasma fructose explains sex differences in multiple cardiovascular risk factors
- 15 October 2025
- Published by Elsevier in Clinical Nutrition ESPEN
- Vol. 70, 360-372
Plasma fructose explains sex differences in multiple cardiovascular risk factors
- Open Access
- 22 August 2025
- Published by Cambridge University Press (CUP) in British Journal of Nutrition
- Vol. 134 (5) , 401-412
Association of two cut-off points for the n -3 index with cardiometabolic risk factors in Brazilian and Puerto Rican middle-aged adults
The n -3 index has been proposed as a risk factor for CVD endpoints. However, the association of the O3I defined with different cut-offs and cardiometabolic risk factors has been less studied. This study aimed to investigate the association between two cut-off points of the O3I and cardiometabolic risk factors in Brazilian and Puerto Rican adults. This cross-sectional analysis included 249 Brazilians and 1261 Puerto Ricans, aged 45–75 years. Fatty acids composition was quantified in erythrocyte membranes using GC with a flame ionisation detector. The O3I was categorised as ≤ 4 % (low), > 4–8 % (intermediate) and ≥ 8 % (desirable), and as ≤ 4 % (very low), > 4–6 % (low), > 6–8 % (moderate) and > 8 % (high) in the second cut-off classification. Serum lipids, waist circumference and insulin resistance were measured from standardised protocols. Multivariable-adjusted linear models tested the association between the O3I and cardiometabolic factors. Brazilians had a mean ( sd ) O3I of 4·65 % (1·19 %) v . 4·43 % (1·14 %) in Puerto Ricans ( P = 0·033), with only 1·6 % of Brazilians and 1·2 % of Puerto Ricans presenting a desirable/high O3I. The O3I, as continuous or for > 4 % ( v . ≤ 4 %), was inversely associated with TAG, VLDL and TAG/HDL-cholesterol ratio in Puerto Ricans. In Brazilians, an O3I > 6 % ( v . ≤ 6 %) was associated with higher total cholesterol, LDL-cholesterol and non-HDL-cholesterol. Both populations presented O3I below the desirable levels, and the magnitude and direction of associations with cardiometabolic factors varied by study and cut-offs, reinforcing the importance of expanding these investigations to more diverse populations.
- 22 August 2025
- Published by Cambridge University Press (CUP) in British Journal of Nutrition
- Vol. 134 (5) , 401-412
Open AccessAssociation of two cut-off points for the n -3 index with cardiometabolic risk factors in Brazilian and Puerto Rican middle-aged adults
The n -3 index has been proposed as a risk factor for CVD endpoints. However, the association of the O3I defined with different cut-offs and cardiometabolic risk factors has been less studied. This study aimed to investigate the association between two cut-off points of the O3I and cardiometabolic risk factors in Brazilian and Puerto Rican adults. This cross-sectional analysis included 249 Brazilians and 1261 Puerto Ricans, aged 45–75 years. Fatty acids composition was quantified in erythrocyte membranes using GC with a flame ionisation detector. The O3I was categorised as ≤ 4 % (low), > 4–8 % (intermediate) and ≥ 8 % (desirable), and as ≤ 4 % (very low), > 4–6 % (low), > 6–8 % (moderate) and > 8 % (high) in the second cut-off classification. Serum lipids, waist circumference and insulin resistance were measured from standardised protocols. Multivariable-adjusted linear models tested the association between the O3I and cardiometabolic factors. Brazilians had a mean ( sd ) O3I of 4·65 % (1·19 %) v . 4·43 % (1·14 %) in Puerto Ricans ( P = 0·033), with only 1·6 % of Brazilians and 1·2 % of Puerto Ricans presenting a desirable/high O3I. The O3I, as continuous or for > 4 % ( v . ≤ 4 %), was inversely associated with TAG, VLDL and TAG/HDL-cholesterol ratio in Puerto Ricans. In Brazilians, an O3I > 6 % ( v . ≤ 6 %) was associated with higher total cholesterol, LDL-cholesterol and non-HDL-cholesterol. Both populations presented O3I below the desirable levels, and the magnitude and direction of associations with cardiometabolic factors varied by study and cut-offs, reinforcing the importance of expanding these investigations to more diverse populations.
- Open Access
An Adapted Cardioprotective Diet with or Without Phytosterol and/or Krill Oil Supplementation in Familial Hypercholesterolemia: Results of a Pilot Randomized Clinical Trial
Background/Objectives: Familial hypercholesterolemia (FH) is an increasingly common inherited disorder that increases cardiovascular risk. Despite the importance of lifestyle interventions, adherence to a healthy diet among individuals with FH remains suboptimal. This pilot, multicenter, double-blind, placebo-controlled randomized trial aimed to evaluate the feasibility and preliminary effects of a culturally adapted cardioprotective diet (DICA-FH), alone or in combination with phytosterol and/or krill oil supplementation, on lipid parameters in Brazilian adults with probable or definitive FH. Methods: Between May and August 2023, 58 participants were enrolled across nine Brazilian centers and randomized (1:1:1:1) into four groups: DICA-FH + phytosterol placebo + krill oil placebo; DICA-FH + phytosterol 2 g/day + krill oil placebo; DICA-FH + phytosterol placebo + krill oil 2 g/day; and DICA-FH + phytosterol 2 g/day + krill oil 2 g/day. Interventions lasted 120 days. The primary outcomes were mean low-density lipoprotein cholesterol (LDL-c) and lipoprotein(a) (Lp[a]) levels, as well as adherence to treatment at follow-up. Secondary outcomes included mean levels of other lipids, frequency of adverse events, and assessment of protocol implementation components. All data were presented separately for the allocation groups: phytosterol vs. placebo and krill oil vs. placebo. Results: Mean age was 54.5 ± 13.7 years, and 58.6% were women. Both adherence to protocol (91.8% attendance; 79.1% investigational product intake) and retention (86.2%) were high. No significant differences between groups were found for LDL-c or Lp(a). However, regardless of allocation to active supplementation or placebo, a significant reduction in Lp(a) concentrations was observed following the DICA-FH intervention (median difference: −3.8 mg/dL [interquartile range: −7.5 to −1.2]; p < 0.01). Significant reductions in oxidized LDL (LDL-ox) and LDL-ox/LDL-c ratio were also observed in the overall sample (p < 0.01). Although not statistically significant, all groups showed improvements in diet quality after 120 days. No serious adverse events related to the interventions were reported. Additionally, most protocol implementation components were successfully achieved. Conclusions: The DICA-FH strategy, with or without supplementation, was safe and well-tolerated. Although not powered to detect clinical efficacy (which is acceptable in exploratory pilot trials), the study supports the feasibility of a larger trial and highlights the potential of dietary interventions in the management of HF.
Open AccessAn Adapted Cardioprotective Diet with or Without Phytosterol and/or Krill Oil Supplementation in Familial Hypercholesterolemia: Results of a Pilot Randomized Clinical Trial
Background/Objectives: Familial hypercholesterolemia (FH) is an increasingly common inherited disorder that increases cardiovascular risk. Despite the importance of lifestyle interventions, adherence to a healthy diet among individuals with FH remains suboptimal. This pilot, multicenter, double-blind, placebo-controlled randomized trial aimed to evaluate the feasibility and preliminary effects of a culturally adapted cardioprotective diet (DICA-FH), alone or in combination with phytosterol and/or krill oil supplementation, on lipid parameters in Brazilian adults with probable or definitive FH. Methods: Between May and August 2023, 58 participants were enrolled across nine Brazilian centers and randomized (1:1:1:1) into four groups: DICA-FH + phytosterol placebo + krill oil placebo; DICA-FH + phytosterol 2 g/day + krill oil placebo; DICA-FH + phytosterol placebo + krill oil 2 g/day; and DICA-FH + phytosterol 2 g/day + krill oil 2 g/day. Interventions lasted 120 days. The primary outcomes were mean low-density lipoprotein cholesterol (LDL-c) and lipoprotein(a) (Lp[a]) levels, as well as adherence to treatment at follow-up. Secondary outcomes included mean levels of other lipids, frequency of adverse events, and assessment of protocol implementation components. All data were presented separately for the allocation groups: phytosterol vs. placebo and krill oil vs. placebo. Results: Mean age was 54.5 ± 13.7 years, and 58.6% were women. Both adherence to protocol (91.8% attendance; 79.1% investigational product intake) and retention (86.2%) were high. No significant differences between groups were found for LDL-c or Lp(a). However, regardless of allocation to active supplementation or placebo, a significant reduction in Lp(a) concentrations was observed following the DICA-FH intervention (median difference: −3.8 mg/dL [interquartile range: −7.5 to −1.2]; p < 0.01). Significant reductions in oxidized LDL (LDL-ox) and LDL-ox/LDL-c ratio were also observed in the overall sample (p < 0.01). Although not statistically significant, all groups showed improvements in diet quality after 120 days. No serious adverse events related to the interventions were reported. Additionally, most protocol implementation components were successfully achieved. Conclusions: The DICA-FH strategy, with or without supplementation, was safe and well-tolerated. Although not powered to detect clinical efficacy (which is acceptable in exploratory pilot trials), the study supports the feasibility of a larger trial and highlights the potential of dietary interventions in the management of HF.