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Feasibility Testing of Plant-Based Supplemented Food Products Made With Manitoba Crop Ingredients for Weight Loss

StatusNot Yet Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 1 year 9 months later Mar 31, 2026 → Dec 31, 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from University of Manitoba

Record History

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  1. Primary and study completion pushed from Mar 31, 2026 to Dec 31, 2027 Show 8 more changesShow less
    • Primary endpoint(s) modified
    • Start date: Sep 1, 2025 to Nov 1, 2026
    • Interventions modified
    • Eligibility criteria expanded, about 20 words
    • Secondary endpoints: 7 to 5
    • Study description expanded, about 159 words
    • Collaborators revised (3)
    • Study title shortened, about 3 words
  2. Start date: Jan 1, 2025 to Sep 1, 2025
    • Site contact updated
    v3
  3. Start date: Nov 1, 2024 to Jan 1, 2025v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The purpose of this study is to advance the development of the WI/CDIC supplemented foods by evaluating the acceptance and feasibility of the supplemented food bars within the Wellness Institute's Weight Loss Clinic program (WLC) or an equivalent weight loss program in Winnipeg or the surrounding area. The main questions it aims to answer are: * To determine whether the incorporation of WI/CDIC supplemented foods into the WI weight loss clinic design is feasible. * To determine whether weight loss is supported by a plant-based supplemented food. * To assess efficacy of the supplemented food by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-supplemented food weight loss program members. Researchers will compare the WLC program plus supplemented food to the WLC program without the supplemented food to evaluate the implementation of the supplemented foods into the WLC. Participants will follow their WLC program for the initial 16 weeks, and those in the intervention group will begin their supplemented food. Participants will consume one supplemented food bar each day and will record this in the product consumption log.
Trial Details
NCT Number NCT06614543
Lead Sponsor University of Manitoba
Collaborators: Seven Oaks Hospital Chronic Disease Innovation Centre, The Wellness Institute, Government of Canada - Agriculture and Agri-Food Canada
Conditions
(from sponsor)		 Weight Loss
Related terms Weight Loss
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov