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Not yet recruiting NCT07142694

Feasibility of Adding a Plant-Based Protein Pudding to the Diet of Older Adults Who Attend a Medically Managed Fitness Facility

No phase Interventional Feasibility Studies Nutrition Intervention

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Plant Based pudding.
Who it may be relevant to
Registry conditions: Feasibility Studies, Nutrition Intervention. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Evaluation of a Plant-based Protein Pudding In Older Adults Attending a Medically Managed Fitness Facility

Overview

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.

Interventions

  • Dietary supplement Plant Based pudding
    Will consume one high protein plant based pudding daily for 7-days per week for 12 weeks

Primary outcome measures

  • Eligibility to Randomization Ratio for Feasibility [Time frame: Measured upon study completion after 12-weeks]
  • Recruitment Rate [Time frame: during 12 months]
  • Follow up rate [Time frame: Measured at end of 12 weeks]
  • Adherence to Intervention [Time frame: Measured at the end of 12 weeks]
Secondary outcome measures (12)
  • Serum Pre-Albumin [Time frame: Measured at Baseline Week 1 and at the end of 12 weeks.]
  • Blood Amino Acid Profile [Time frame: Measured at Baseline Week 1 and at the end of week 12]
  • Dry Weight [Time frame: Measured at Baseline Week 1 and after the end of week 12]
  • Waist Circumsference [Time frame: Measured at Baseline Week 1 and after the end of week 12]
  • Lean mass [Time frame: At the baseline week 1 and at end of week 12]
  • Fat Mass [Time frame: At the baseline week 1 and at end of week 12]
  • Physical function; Five rep chair stand time test [Time frame: Measured at Baseline Week 1 and after the end of week 12]
  • Blood Pressure [Time frame: Measured at Baseline Week 1 and after the end of week 12]
  • Total Calories intake [Time frame: Measured at Baseline Week 1 and after the end of week 12]
  • Carbohydrates [Time frame: At the baseline week 1 and at end of week 12]
  • Protein [Time frame: At the baseline week 1 and at end of week 12]
  • Fat [Time frame: At the baseline week 1 and at end of week 12]

Eligibility criteria

Inclusion criteria

  • 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),

Exclusion criteria

  • 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. )

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • Chronic Disease Innovation Centre — Winnipeg

Identifiers

NCT: NCT07142694 · HS26887 (B2025:025)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗