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.
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),
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. )
Parallel
Plant Based pudding
Dietary supplementWill consume one high protein plant based pudding daily for 7-days per week for 12 weeks
Eligibility to Randomization Ratio for Feasibility
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
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
Follow-up rate (% of participant outcomes) will be calculated if more than \>85% of participant outcomes
Adherence to Intervention
Adherence to plant based pudding intervention if more than (75% of dispensed plant based pudding protein is consumed)
Serum Pre-Albumin
Serum albumin is measured in grams per deciliter (g/dL)
Blood Amino Acid Profile
blood amino acid profile
Dry Weight
Changes in body weight (Kg)
Waist Circumsference
Measured in cm
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This trial is not recruiting at the moment. You can still explore other options:
