Plant-based Diet in Older People: What Consequences for Muscle Health?
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Maximal Quadriceps Strength
研究概览
简要总结
This randomized, controlled, two-arm clinical study aims to determine how increasing the proportion of plant-based foods in the diet affects skeletal muscle strength, mass and function, protein metabolism, microbiota and key metabolic markers in healthy older men and women. We hypothesize that diets enriched with animal-based foods will maintain maximal quadriceps strength-the primary outcome of the study-more effectively after the 3-month nutritional intervention than plant-based diets. Proteomic analyses will be performed to identify molecular mechanisms and potential muscle biomarkers reflecting metabolic adaptations of skeletal muscle to plant-enriched diets. In addition, metabolic health markers and micronutrient status will be evaluated to better understand the overall health effects of dietary plant-based transition in older adults.
详细描述
This exploratory, open-label, randomized, controlled, two-arm clinical study aims to evaluate how increasing the proportion of plant-based foods in the diet affects skeletal muscle health in older adults. The primary objective is to assess the impact of a plant-enriched diet on physical performance, specifically maximal quadriceps strength after a 3-month nutritional intervention.
Secondary objectives are to determine the effects of a plant-enriched diet on: (1) whole-body and muscle protein metabolism, (2) modifications in the skeletal muscle proteome and metabolome, (3) functional capacities, (4) body composition, (5) gut microbiota composition, and (6) sex-related differences in metabolic adaptability. The study will compare diets containing different proportions of plant-based foods in healthy older men and women.
Participants will undergo medical evaluation, nutritional follow-up, body composition measurements, muscle function testing, indirect calorimetry, and biological sampling including blood tests, and microbiota profiling. BBlood samples will be collected for proteomic and metabolomic analyses to identify molecular pathways and potential muscle biomarkers associated with adaptations to plant-enriched diets. In parallel, circulating amino acid concentrations will be measured to assess protein bioavailability, and blood samples will be incubated with skeletal muscle cells to evaluate the anabolic potential of the ingested proteins. Digestive tolerance, micronutrient status, and metabolic health markers will also be monitored.
The procedures are associated with minimal anticipated risks. Blood sampling may cause bruising and indirect calorimetry may result in mild discomfort. Plant-enriched diets may induce transient digestive symptoms or weight loss, which will be closely monitored. Participants experiencing clinically significant weight loss will be withdrawn from the intervention and followed until stabilization.
The findings of this study may strengthen public health recommendations promoting sustainable dietary transitions in older adults and help develop nutritional strategies aimed at maintaining optimal muscle health and supporting healthy aging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
This is an open-label study. Participants and investigators are aware of the assigned diets due to meal preparation and individualized dietary support. Outcome assessments are conducted without blinding.
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women aged 65 years and older
- •Body Mass Index (BMI) between 18.5 and 30 kg/m² (exclusive)
- •Physical activity < 3000 MET-min/week, assessed using the ONAPS-PAQ questionnaire
- •Laboratory tests compatible with participation in the study
- •Adequate venous status, as assessed by study nurses, allowing catheter placement
- •Willingness to participate in study procedures, including indirect calorimetry, functional tests, and assigned dietary intervention (plant-enriched or standard diet)
- •Affiliation with the French Social Security system
排除标准
- •Men and women aged 65 years and older
- •Body Mass Index (BMI) between 18.5 and 30 kg/m² (exclusive)
- •Physical activity < 3000 MET-min/week, assessed using the ONAPS-PAQ questionnaire
- •Laboratory tests compatible with participation in the study
- •Adequate venous status, as assessed by study nurses, allowing catheter placement
- •Willingness to participate in study procedures, including indirect calorimetry, functional tests, and assigned dietary intervention (plant-enriched or standard diet)
- •Affiliation with the French Social Security system
- •Exclusion period from a previous study or total compensation exceeding €6,000 in the 12 months prior to study initiation (verified through the National Research Volunteer Database)
- •Patients under legal guardianship, curatorship, deprived of liberty, or under judicial protection
- •Claustrophobia
结局指标
主要结局
Maximal Quadriceps Strength
时间窗: Baseline and Month 3
Maximal voluntary contraction of the quadriceps muscle will be measured using a standardized dynamometer. This outcome evaluates the primary effect of the dietary intervention on skeletal muscle strength in older adults.
次要结局
- Protein metabolism(Baseline and Month 3)
- Short Physical Performance Battery (SPPB) total score(Baseline and Month 3)
- Handgrip strength(Baseline and Month 3)
- Distance covered during the 6-minute walk test(Baseline and Month 3)
- Appendicular lean mass(Baseline and Month 3)
- Relative abundance of dominant gut bacterial taxa(Baseline and Month 3)
- Sex-specific changes in maximal quadriceps strength(Baseline and Month 3)
- Sex-specific changes in serum metabolomic and proteomic profiles(Baseline and Month 3)
- Sex-specific changes in appendicular lean mass(Baseline and Month 3)