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

NCT04458493 | Unknown

• 1 other identifier: 116302
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• changes in waist and hip circumferences

  1 day prior to the start of the experiment and on the 31st day of the experiment

• changes in fasted blood glucose

  1 day prior to the start of the experiment and on the 31st day of the experiment

• changes in appetite ratings

  30, 60 and 120 minutes after each meal replacement drink

• changes in desire to eat ratings

  30, 60 and 120 minutes after each meal replacement drink

Study Arms (2)

control

EXPERIMENTAL

no supplement will be provided on the day of the experiment

Behavioral: satiety

Generation UCAN

EXPERIMENTAL

carbohydrates - protein (Generation UCAN supplement, 400ml, 20% solution)

Behavioral: satiety; Dietary Supplement: Dietary Supplement: Generation UCAN supplementation

Interventions

satiety BEHAVIORAL

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

Generation UCAN; control

Dietary Supplement: Generation UCAN supplementation DIETARY_SUPPLEMENT

meal replacement, Generation UCAN supplement, 400ml, 20% solution

Generation UCAN

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• sedentary (\<2 moderate exercise bouts/wk)
• between the ages of 18 to 40y
• body mass index (BMI) between \>25

You may not qualify if:

• do not eat three meals a day typically
• taking medication that affects their eating patterns
• have metabolic and gastrointestinal diseases

Sponsors & Collaborators

• Western University, Canada: lead

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Peter Lemon, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Crystal Lee, BSc

CONTACT

519 6612111; plee263@uwo.ca

Manuel Manuel, MSc

CONTACT

519 6612111; mquinon2@uwo.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 7, 2020
• Study Start: August 1, 2020
• Primary Completion: January 1, 2021
• Study Completion: July 1, 2021
• Last Updated: July 29, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share