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

NCT07142694 | Not Yet Recruiting

• 1 other identifier: HS26887 (B2025:025)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Feasibility Studies; Nutrition Intervention

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (13)

• Serum Pre-Albumin

  Measured at Baseline Week 1 and at the end of 12 weeks.

• 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

• Waist Circumsference

  Measured at Baseline Week 1 and after the end of week 12

• Lean mass

  At the baseline week 1 and at end of week 12

Study Arms (2)

Plant Based Pudding

EXPERIMENTAL

Participants will consume plant based pudding daily for 7 days per week

Dietary Supplement: Plant Based pudding

Continue with their current lifestyle

NO INTERVENTION

Participants will continue with their current lifestyle without intervention

Interventions

Plant Based pudding DIETARY_SUPPLEMENT

Will consume one high protein plant based pudding daily for 7-days per week for 12 weeks

Plant Based Pudding

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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),

You may not qualify if:

• 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. )

Sponsors & Collaborators

• Seven Oaks Hospital Chronic Disease Innovation Centre: lead

Study Sites (1)

Chronic Disease Innovation Centre

Winnipeg, Manitoba, R2V 3M3, Canada

Location

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: This trial is a randomized controlled parallel arm feasibility trial

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 27, 2025
• Study Start: January 15, 2026
• Primary Completion: April 15, 2026
• Study Completion: May 1, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)