Evaluation of a Plant-based Protein Pudding In Older Adults Attending a Medically Managed Fitness Facility
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Eligibility to Randomization Ratio for Feasibility
研究概览
简要总结
The goal of this a 12-week randomized controlled parallel arm feasibility trial is to evaluate the feasibility and acceptability of incorporating a plant-based protein pudding into the diets of older adults who attend a medically managed fitness facility. The primary participant population includes older adults, aged 60 years and above, who are generally healthy and engaged in structured fitness programs.
The main questions it aims to answer are:
Is a plant-based protein pudding acceptable and well-tolerated by older adults? Does regular consumption of the pudding support muscle health and overall well-being in this population?
Participants will:
Consume a plant-based protein pudding as one arm daily for 7 days per week (experimental) and the other will continue their current lifestyle (control).
The experimental group will complete surveys or questionnaires to assess acceptability, taste, and ease of integration into daily meals.
Undergo basic physical or health assessments (e.g., muscle function or strength evaluations) to evaluate potential effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participant is willing and able to give informed consent for participation in the trial
- •Male or female aged ≥60 years
- •Actively attend the Wellness Institute (≥8 times in the past 28 days),
排除标准
- •Allergy to ingredients in the study treatment
- •Inability to consume treatment product
- •Inability to obtain written informed consent
- •Apart of any physical rehab program at WI (cardiac rehab, kidney fit, etc. )
研究组 & 干预措施
Plant Based Pudding
Participants will consume plant based pudding daily for 7 days per week
干预措施: Plant Based pudding (Dietary Supplement)
Continue with their current lifestyle
Participants will continue with their current lifestyle without intervention
结局指标
主要结局
Eligibility to Randomization Ratio for Feasibility
时间窗: Measured upon study completion after 12-weeks
A ratio of eligibility to randomization will be collected at 12 months. The trial will be considered feasible if ratio falls within \>0.5, calculated as the ratio of individuals who were randomized to the trial to the number eligible to participate who were approached to participate.
Recruitment Rate
时间窗: during 12 months
Recruitment rate will be assessed as the average number of new participants enrolled per site per week during the active recruitment period, with a target of ≥0.5 participants per site per week.
Follow up rate
时间窗: Measured at end of 12 weeks
Follow-up rate (% of participant outcomes) will be calculated if more than \>85% of participant outcomes
Adherence to Intervention
时间窗: Measured at the end of 12 weeks
Adherence to plant based pudding intervention if more than (75% of dispensed plant based pudding protein is consumed)
次要结局
- Lean mass(At the baseline week 1 and at end of week 12)
- Blood Amino Acid Profile(Measured at Baseline Week 1 and at the end of week 12)
- Dry Weight(Measured at Baseline Week 1 and after the end of week 12)
- Carbohydrates(At the baseline week 1 and at end of week 12)
- Waist Circumsference(Measured at Baseline Week 1 and after the end of week 12)
- Fat Mass(At the baseline week 1 and at end of week 12)
- Physical function; Five rep chair stand time test(Measured at Baseline Week 1 and after the end of week 12)
- Serum Pre-Albumin(Measured at Baseline Week 1 and at the end of 12 weeks.)
- Blood Pressure(Measured at Baseline Week 1 and after the end of week 12)
- Total Calories intake(Measured at Baseline Week 1 and after the end of week 12)
- Protein(At the baseline week 1 and at end of week 12)
- Fat(At the baseline week 1 and at end of week 12)
- Fiber (total dietary fiber)(At the baseline week 1 and at end of week 12)