Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plant Based Pudding | Experimental | Participants will consume plant based pudding daily for 7 days per week |
|
| Continue with their current lifestyle | No Intervention | Participants will continue with their current lifestyle without intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant Based pudding | Dietary Supplement | Will consume one high protein plant based pudding daily for 7-days per week for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured upon study completion after 12-weeks |
| 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. | during 12 months |
| Follow up rate | Follow-up rate (% of participant outcomes) will be calculated if more than >85% of participant outcomes | Measured at end of 12 weeks |
| Adherence to Intervention | Adherence to plant based pudding intervention if more than (75% of dispensed plant based pudding protein is consumed) | Measured at the end of 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum Pre-Albumin | Serum albumin is measured in grams per deciliter (g/dL) | Measured at Baseline Week 1 and at the end of 12 weeks. |
| Blood Amino Acid Profile | blood amino acid profile |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Navdeep Tangri Dr. Tangri, MD, PhD | Contact | 204-631-3834 | NTangri@sogh.mb.ca | |
| Maryem Zahra, BA | Contact | 204-631-3834 | MZahra@sogh.mb.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chronic Disease Innovation Centre | Winnipeg | Manitoba | R2V 3M3 | Canada |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This trial is a randomized controlled parallel arm feasibility trial
Not provided
Not provided
Not provided
| Measured at Baseline Week 1 and at the end of week 12 |
| Dry Weight | Changes in body weight (Kg) | Measured at Baseline Week 1 and after the end of week 12 |
| Waist Circumsference | Measured in cm | Measured at Baseline Week 1 and after the end of week 12 |
| Lean mass | Measured in Kg | At the baseline week 1 and at end of week 12 |
| Fat Mass | Measured in Kg | At the baseline week 1 and at end of week 12 |
| Physical function; Five rep chair stand time test | the amount of time it takes for a participant to get up out of a chair five times measured in seconds | Measured at Baseline Week 1 and after the end of week 12 |
| Blood Pressure | Systolic and Diastolic Blood Pressure Measured in mmHg | Measured at Baseline Week 1 and after the end of week 12 |
| Total Calories intake | Using RxFoods- Diet recall change in total calories measured in kcal/day | Measured at Baseline Week 1 and after the end of week 12 |
| Carbohydrates | Measured as g/day | At the baseline week 1 and at end of week 12 |
| Protein | Measured as g/day | At the baseline week 1 and at end of week 12 |
| Fat | Measured as g/day | At the baseline week 1 and at end of week 12 |
| Fiber (total dietary fiber) | Measured as g/day | At the baseline week 1 and at end of week 12 |