Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06614543
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-23
Brief Title:
Feasibility Testing of Plant-Based Meal Replacement Products Made with Manitoba Crop Ingredients for Weight Loss and Diabetes Remission
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Testing of Plant-Based Meal Replacement Products Made with Manitoba Crop Ingredients for Weight Loss and Diabetes Remission
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to advance the development of the WI meal replacements by evaluating the acceptance and feasibility of the meal replacements within the Wellness Institutes Weight Loss Clinic program WLC The main questions it aims to answer are
To determine whether the incorporation of WI meal replacements into their weight loss clinic design is feasible
To determine whether weight loss is supported by a plant-based meal replacement
To assess efficacy of the meal replacements by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-meal replacement weight loss program members
To assess remission of diabetes and pre-diabetes
Researchers will compare the WLC program plus meal replacements to the WLC program without the meal replacements to evaluate the implementation of the meal replacements into the WLC
Participants will follow their WLC program for 16 weeks and those in the intervention group will begin their meal replacements Participants will have a choice on what type of meal replacement they will consume each day either a bar or a shake and will record this in the product consumption log
To determine whether the incorporation of WI meal replacements into their weight loss clinic design is feasible
To determine whether weight loss is supported by a plant-based meal replacement
To assess efficacy of the meal replacements by measuring changes in lifestyle behaviours and risk factors for chronic disease compared to non-meal replacement weight loss program members
To assess remission of diabetes and pre-diabetes
Researchers will compare the WLC program plus meal replacements to the WLC program without the meal replacements to evaluate the implementation of the meal replacements into the WLC
Participants will follow their WLC program for 16 weeks and those in the intervention group will begin their meal replacements Participants will have a choice on what type of meal replacement they will consume each day either a bar or a shake and will record this in the product consumption log
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None