Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?
Primary Purpose
Weight Loss
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
satiety
Dietary Supplement: Generation UCAN supplementation
Sponsored by
About this trial
This is an interventional other trial for Weight Loss
Eligibility Criteria
Inclusion Criteria:
- sedentary (<2 moderate exercise bouts/wk)
- between the ages of 18 to 40y
- body mass index (BMI) between >25
Exclusion Criteria:
- do not eat three meals a day typically
- taking medication that affects their eating patterns
- have metabolic and gastrointestinal diseases
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
control
Generation UCAN
Arm Description
no supplement will be provided on the day of the experiment
carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)
Outcomes
Primary Outcome Measures
changes in body weight
body weight will be measured using a scale at home prior to breakfast
Secondary Outcome Measures
changes in waist and hip circumferences
waist and hip circumferences will be measured using a measuring tape at home prior to breakfast
changes in fasted blood glucose
blood glucose will be measured through finger pricks
changes in appetite ratings
appetite ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being strong desire to consume food and 1 being no desire to consume food at all
changes in desire to eat ratings
desire to eat ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being no desire to eat at all and 1 being strong desire to eat
Full Information
NCT ID
NCT04458493
First Posted
June 29, 2020
Last Updated
July 28, 2020
Sponsor
Western University, Canada
1. Study Identification
Unique Protocol Identification Number
NCT04458493
Brief Title
Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?
Official Title
Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
July 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Western University, Canada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Participants will be randomized into two groups, one group will be the control (no intervention at all) and the other will be CHO-PRO (meal replacement, Generation UCAN supplement, 400ml, 20% solution). Prior to the start of the experiment, all participants will be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after their regular dinner for 3 days. On the first day of the experiment, all participants will be asked to measure their waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast. Instructions on how to do the measurements properly will be recorded in a video and distributed to the participants. Participants in the control group will not receive any intervention. Participants in the CHO-PRO group will be provided with the supplement and they will be asked to consume the CHO - protein supplement (Generation UCAN supplement, 250ml, 10% solution) 6 to 7 hours after lunch, in place of their dinner for 6 weeks. They will also be asked to record their satiety ratings, appetite and desire to eat (10-point visual analogue scale) 30, 60 and 120 minutes after each meal replacement drink. All participants will be required to complete a dietary record, prior to, and during (at weeks 2 and 4) intervention. To track adherence of the CHO-PRO group, participants will be asked to check off the calendar that they did not consume the meal replacement due to various reasons. On day 43, all participants will be asked measure again waist and hip circumferences, fasting blood glucose level, maximal number of pushups and body weight using a scale at home prior to breakfast again.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control
Arm Type
Experimental
Arm Description
no supplement will be provided on the day of the experiment
Arm Title
Generation UCAN
Arm Type
Experimental
Arm Description
carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)
Intervention Type
Behavioral
Intervention Name(s)
satiety
Intervention Description
satiety ratings, appetite and desire to eat (10-point visual analogue scale) will be measured at 30, 60 and 120 minutes after each meal replacement drink
Intervention Type
Dietary Supplement
Intervention Name(s)
Dietary Supplement: Generation UCAN supplementation
Intervention Description
meal replacement, Generation UCAN supplement, 400ml, 20% solution
Primary Outcome Measure Information:
Title
changes in body weight
Description
body weight will be measured using a scale at home prior to breakfast
Time Frame
1 day prior to the start of the experiment and on the 31st day of the experiment
Secondary Outcome Measure Information:
Title
changes in waist and hip circumferences
Description
waist and hip circumferences will be measured using a measuring tape at home prior to breakfast
Time Frame
1 day prior to the start of the experiment and on the 31st day of the experiment
Title
changes in fasted blood glucose
Description
blood glucose will be measured through finger pricks
Time Frame
1 day prior to the start of the experiment and on the 31st day of the experiment
Title
changes in appetite ratings
Description
appetite ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being strong desire to consume food and 1 being no desire to consume food at all
Time Frame
30, 60 and 120 minutes after each meal replacement drink
Title
changes in desire to eat ratings
Description
desire to eat ratings will be asked with the use a 10 point visual analog scale (VAS), 10 being no desire to eat at all and 1 being strong desire to eat
Time Frame
30, 60 and 120 minutes after each meal replacement drink
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
sedentary (<2 moderate exercise bouts/wk)
between the ages of 18 to 40y
body mass index (BMI) between >25
Exclusion Criteria:
do not eat three meals a day typically
taking medication that affects their eating patterns
have metabolic and gastrointestinal diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Crystal Lee, BSc
Phone
519 6612111
Email
plee263@uwo.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Manuel Manuel, MSc
Phone
519 6612111
Email
mquinon2@uwo.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Lemon, PhD
Organizational Affiliation
Western University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?
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