Naotake Yanagisawa

Background/Objectives: Sarcopenia contributes to frailty and functional decline in older adults; however, effective adjunctive strategies remain limited. Heat-killed Bifidobacterium breve B-3 (B-3HK), a postbiotic, has shown muscle-related effects in preclinical studies; however, clinical evidence in patients with established sarcopenia is scarce. This pilot trial aimed to evaluate these clinical effects. Methods: In this 24-week randomized, double-blind, placebo-controlled trial, adults aged 50–89 years with Asian Working Group for Sarcopenia (AWGS) 2019-defined sarcopenia received B-3HK (2 × 10¹⁰ cells/day) or placebo daily. The primary outcome was the change in knee extension strength at week 24. Secondary outcomes included body composition measured using bioelectrical impedance analysis (BIA), dual-energy X-ray absorptiometry (DXA), physical performance, Eating Assessment Tool-10 (EAT-10), serum biomarkers, gut microbiota, and safety. Secondary outcomes were exploratory with nominal p-values and no adjustment for multiple comparisons. Results: Fifty participants were randomized, and 49 were included in the full analysis set. Compared with placebo, B-3HK did not significantly improve knee extension strength. Exploratory analyses showed between-group differences favoring B-3HK in the BIA-derived skeletal muscle mass index, limb muscle mass, EAT-10 score, and serum insulin-like growth factor-1 and 25-hydroxyvitamin D levels. These differences were primarily driven by the attenuation of the decline in the placebo group and were not corroborated by DXA-derived indices or functional outcomes. The gut microbiota composition did not differ between groups. No serious adverse events were observed. Conclusions: B-3HK did not improve muscle strength in patients with sarcopenia. Exploratory analyses identified nominal between-group differences in body composition and endocrine outcomes; however, these findings were unadjusted for multiplicity and should be regarded as hypothesis-generating rather than confirmatory evidence of efficacy. These data may help inform the design of future adequately powered trials, but confirmation is required before any therapeutic benefit can be inferred.

Background: Olanzapine 5 mg improves chemotherapy-induced nausea and vomiting (CINV) control in patients receiving anthracycline–cyclophosphamide (AC) chemotherapy, but sedation remains a concern. We evaluated whether central nervous system (CNS) symptom burden identifies patients at higher risk of poor CINV control. Patients and methods: This secondary analysis of the phase III JTOP-B trial included women with breast cancer receiving AC chemotherapy. Patients were randomized to olanzapine 5 mg or placebo plus standard triplet antiemetic therapy. Daily patient-reported sedation and concentration impairment were assessed for 5 days. CNS burden was evaluated using recurrent “Bad Days” (concurrent moderate/severe sedation and concentration impairment) and cumulative CNS burden scores. Associations between CNS symptom patterns and complete response (CR; no emesis and no rescue medication) during 0-120 hours were analyzed. Results: Among 480 patients, CR rates decreased with increasing CNS symptom severity in both groups. In the olanzapine group, CR rates decreased across increasing sedation (75.0%-51.6%) and concentration impairment (78.1%-48.6%). Concentration impairment more strongly identified patients with poor CINV control than sedation alone. Higher cumulative CNS burden and recurrent Bad Days were associated with lower CR rates, identifying a clinically vulnerable population. Olanzapine maintained higher CR rates than placebo across CNS symptom strata. Conclusions: CNS symptom burden was associated with suboptimal CINV control, while 5 mg of olanzapine maintained superior antiemetic efficacy across CNS symptom strata. Monitoring day-to-day CNS symptoms may help identify patients requiring closer observation or additional supportive care. Trial registration: Japan Registry of Clinical Trials Identifier: jRCT1031200134

Background: Japan is likely the world’s leading aging society, and when leveraged effectively, digital health services hold great potential for addressing health care system challenges. Appropriate development and facilitation of these services require the evaluation of users’ digital health literacy. However, the status of digital health literacy in Japan, especially among older adults, remains unclear, which limits efforts to effectively promote such services. Objective: This study aimed to translate the eHealth Literacy Questionnaire (eHLQ) into Japanese and test the translation’s reliability. Additionally, it aimed to examine eHLQ scores among Japan’s population, compare them across various backgrounds, and explore considerations for applying digital health systems to support Japan’s aging society. Methods: A sequential exploratory mixed methods design was employed. The translation process prioritized achieving conceptual equivalence with the source language. To evaluate the translation’s reliability, psychometric assessments by survey were conducted based on classical test theory and item response theory. Comparative statistical analysis was used to examine the impact of demographic factors. Results: A total of 504 individuals aged 18-88 years completed the survey, with 444 responding online and 60 in face-to-face interviews. The Japanese eHLQ showed good internal consistency, with Cronbach α values ≥0.78. The comparative fit index was >0.95, standardized root mean residual was ≤0.04, and standardized expected parameter change was ≤0.23, indicating good to acceptable fit. Item response theory analysis found adequate item location, discrimination, and factor loading. Boundary characteristic curve plotting demonstrated that all items fit well. Participants with more frequent digital health service use and better self-reported health status showed higher eHLQ scores across all 7 scales: (1) Using technology to process health information, (2) Understanding of health concepts and language, (3) Ability to actively engage with digital services, (4) Feel safe and in control, (5) Motivated to engage with digital services, (6) Access to digital services that work, and (7) Digital services that suit individual needs. Conclusions: The Japanese version of the eHLQ is robust and is likely to be a reliable and effective tool for assessing digital health literacy among Japan’s population. There were no notable differences between scores of those aged above and below 65 years, or those with and without chronic disease(s). The findings also suggest that current systems may be tailored to frequent digital health users. The Japanese version of the eHLQ is expected to be used to effectively monitor digital health literacy in Japan’s aging society.

Background: Oral probiotic intake is suggested to have positive effects on skin. We aimed to elucidate the effects of oral Bifidobacterium breve M-16V intake on skin by analyzing facial images, the skin myco/microbiota, and the gut microbiota. Methods: We conducted a randomized, double-blind, placebo-controlled study in Japan. Healthy women aged over 30 years were randomly allocated to either the B. breve (1 × 1010 colony-forming units (CFU)/sachet, two sachets daily) or the placebo group and consumed the corresponding study food for 12 weeks. Facial images were taken at weeks 0, 4, 8, and 12 using VISIA evolution. Stool and skin samples were collected at weeks 0 and 12. The primary outcome was the change in the total VISIA score from baseline. Results: A total of 120 females aged 30–79 years were assigned to the B. breve (n = 59) or placebo (n = 61) group. The total VISIA score worsened in the placebo group at week 8 (p = 0.029) but not in the B. breve group. Compared with that of the placebo group, the VISIA brown spot score of the B. breve group improved at weeks 4 (p = 0.013) and 8 (p = 0.041). The VISIA pore score improved at weeks 4 (p = 0.013), 8 (p = 0.041), and 12 (p = 0.004) within the B. breve group. Genus-level analysis of the gut microbiota revealed a significant increase in Blautia abundance in the B. breve group. The frequency of adverse events was not different between the groups. Conclusions: Oral B. breve M-16V administration may suppress skin deterioration, including the appearance of brown spots, on the faces of adult females.

Objective: To clarify the relationship between constipation and depressive symptoms among the elderly. Methods: This single-center, cross-sectional study was performed using baseline data obtained at the time of enrollment in the prospective cohort of the JUSTICE-TOKYO study. Participants underwent assessments including patient profiling, drug use history, the Mini-Mental State Examination (MMSE), the Geriatric Depression Scale 15 (GDS-15), gastrointestinal-related quality of life (QOL), and the constipation scoring system (CSS). Geriatric depressive symptoms were evaluated based on GDS-15. We investigated correlations between GDS-15 scores and various abdominal symptoms and assessed risk factors for geriatric depressive symptoms using multiple regression analysis. Results: A total of 984 elderly participants (57% female, mean age 78.1 ± 6.1 year) were included. The GDS-15 scores were significantly correlated with body mass index (BMI) (r = −0.056) and MMSE (r = −0.092), reflex-related QOL (r = 0.253), pain-related QOL (r = 0.229), fullness-related QOL (r = 0.269), constipation-related QOL (r = 0.329), diarrhea-related QOL (r = 0.264), and CSS (r = 0.285) scores. Multiple regression analysis indicated that BMI (β = −0.069, p = 0.020) and MMSE (β = −0.074, p = 0.013), constipation-related QOL (β = 0.136, p = 0.002), reflex-related QOL (β = 0.126, p < 0.001), diarrhea-related QOL (β = 0.095, p = 0.006), and CSS (β = 0.098, p = 0.016) scores were significantly correlated with GDS-15 scores. Conclusions: Depressive symptoms among older individuals are associated with various abdominal symptoms, particularly constipation. However, the causality between depressive symptoms and constipation cannot be inferred due to the study’s cross-sectional design.

Background/Objectives: Reports on oral frailty as a risk factor for chronic constipation are scarce. In this study, we examined the relationship between Oral Frailty Index-8 (OFI-8) and constipation severity. Methods: This cross-sectional analysis involved patients aged ≥65 years (outpatients between November 2020 and November 2021). Patient background (age, sex, body mass index, medical history, lifestyle history, and oral medications), a constipation severity questionnaire (Constipation Scoring System [CSS]), grip strength, walking speed, skeletal muscle mass index (dual-energy X-ray absorptiometry), a frailty questionnaire, an oral frailty questionnaire (OFI-8), an abdominal symptoms quality of life (QOL) questionnaire (Izumo scale), a swallowing evaluation questionnaire (10-item Eating Assessment Tool [EAT-10]), a chronic obstructive pulmonary disease (COPD) evaluation questionnaire (COPD assessment test [CAT]), a simplified QOL evaluation (EuroQol-five dimensions [EQ-5D]), the Dietary Variety Score, a nutritional evaluation (CONtrolling NUTritional Status [CONUT] score), and the 15-item Geriatric Depression Scale (GDS-15) were analyzed. Risk factors for constipation severity (CSS) were examined using multivariate analysis. Patients with advanced gastrointestinal cancer, inflammatory bowel disease, and active gastroduodenal ulcer were excluded. Results: In total, 1029 patients (male/female: 450/579; mean age: 78.3 ± 6.1 years; mean body mass index: 22.9 ± 3) were included. Multivariate analysis demonstrated a significant association between CSS and OFI-8 (β = 0.065), EAT-10 (β = 0.061), sarcopenia (β = 0.050), laxative (β = 0.126), constipation-related QOL score (β = 0.625), diarrhea-related QOL score (β = −0.064), and CAT (β = 0.061). Conclusions: Comprehensive risk factors associated with CSS included a high oral frailty score, impaired swallowing (EAT-10), sarcopenia, laxative use, a high constipation QOL score, a low diarrhea QOL score, and COPD assessment through CAT.

Background: High blood pressure (BP) is linked to unhealthy lifestyles, and its treatment includes medications and exercise therapy. Many previous studies have evaluated the effects of exercise on BP improvement; however, exercise requires securing a location, time, and staff, which can be challenging in clinical settings. The antihypertensive effects of dance exercise for patients with hypertension have already been verified, and it has been found that adherence and dropout rates are better compared to other forms of exercise. If the burden of providing dance instruction is reduced, dance exercise will become a highly useful intervention for hypertension treatment. Objective: This study aims to investigate the effects of regular exercise therapy using dance videos on the BP of patients with hypertension, with the goal of providing a reference for prescribing exercise therapy that is highly feasible in clinical settings. Methods: This nonblind, double-arm, randomized controlled trial was conducted at Juntendo University, Tokyo, from April to December 2023. A total of 40 patients with hypertension were randomly assigned to either an intervention group (dance) or a control group (self-selected exercise), with each group comprising 20 participants. The intervention group performed daily dance exercises using street dance videos (10 min per video) uploaded to YouTube. The control group was instructed to choose any exercise other than dance and perform it for 10 minutes each day. The activity levels of the participants were monitored using a triaxial accelerometer. BP and body composition were measured on the day of participation and after 2 months. During the intervention period, we did not provide exercise instruction or supervise participants’ activities. Results: A total of 34 patients were included in the study (16 in the intervention group and 18 in the control group). The exclusion criteria were the absence of BP data, medication changes, or withdrawal from the study. The mean age was 56 (SD 9.8) years, and 18 (53%) of the patients were female. The mean BMI was 28.0 (SD 6.3) m/kg2, and systolic blood pressure (SBP) and diastolic blood pressure (DBP) were 139.5 (SD 17.1) mm Hg and 85.8 (SD 9.1) mm Hg, respectively. The basic characteristics did not differ between the two groups. In the multivariate analysis, SBP and DBP improved significantly in the intervention group compared to the control group (mean SBP –12.8, SD 6.1 mm Hg; P=.047; mean DBP –9.7, SD 3.3 mm Hg; P=.006). Conclusions: This study evaluated the effects of dance exercise on patients with hypertension, as previously verified, under the additional condition of using dance videos without direct staff instruction or supervision. The results showed that dance videos were more effective in lowering BP than conventional exercise prescriptions. Trial Registration: University Hospital Medical Information Network UMIN 000051251; https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058446

Objective: To determine the prevalence of frailty and examine its association with gastrointestinal-related quality of life (QOL) among older outpatients in a geriatric hospital. Methods: This cross-sectional study involved 1042 outpatients (age: ≥65 years) diagnosed using the revised Japanese version of the cardiovascular health study criteria. Data collection was performed by a multidisciplinary team. Results: Of the 1039 eligible subjects (male: n = 460 [44.3%]; mean age: 78.2 ± 6.1 years), 172 (16.6%) had frailty (male: n = 77 [44.8%]; mean age: 80.9 ± 6.2 years). The multivariate analysis revealed that age (odds ratio [OR]: 1.070, p < 0.001), QOL (OR: 0.982, p = 0.009), a history of falls (OR: 1.702, p = 0.029), sarcopenia (OR: 4.708, p < 0.001), steroid use (OR: 3.741, p = 0.001), analgesic drug use (OR: 2.056, p = 0.014), Mini Mental State Examination (OR: 0.915, p = 0.011), Geriatric Depression Scale 15 (OR: 1.101, p = 0.008), fullness-related QOL score (OR: 1.119, p = 0.010), chronic obstructive pulmonary disease assessment test (OR: 1.048, p = 0.007), and 10-item Eating Assessment Tool (OR: 1.071, p = 0.009) were related to frailty. Conclusions: The prevalence rate of frailty in older outpatients at a university hospital specializing in geriatric medicine was higher than that previously reported in community-dwelling individuals. Our study clarified that the fullness-related QOL score was related to frailty.