Does Meal Replacement With a Carbohydrates and Protein Supplement Induce Weight Loss in Overweight and/or Obese Adults?

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.

Study Overview

• Status: Unknown
• Conditions: Weight Loss
• Intervention / Treatment: Behavioral: satiety; Dietary supplement: Dietary Supplement: Generation UCAN supplementation

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: control; no supplement will be provided on the day of the experiment	Behavioral: satiety; 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
Experimental: Generation UCAN; carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)	Behavioral: satiety; 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; Dietary supplement: Dietary Supplement: Generation UCAN supplementation; meal replacement, Generation UCAN supplement, 400ml, 20% solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in body weight	body weight will be measured using a scale at home prior to breakfast	1 day prior to the start of the experiment and on the 31st day of the experiment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in waist and hip circumferences	waist and hip circumferences will be measured using a measuring tape at home prior to breakfast	1 day prior to the start of the experiment and on the 31st day of the experiment
changes in fasted blood glucose	blood glucose will be measured through finger pricks	1 day prior to the start of the experiment and on the 31st day of the experiment
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	30, 60 and 120 minutes after each meal replacement drink
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	30, 60 and 120 minutes after each meal replacement drink

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2020
• Primary Completion (Anticipated): January 1, 2021
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 29, 2020
• Last Update Submitted That Met QC Criteria: July 28, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight Changes; Weight Loss; Overweight; Body Weight
• Other Study ID Numbers: 116302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No