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

NCT ID: NCT04458493

Last Updated: 2020-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-01

Study Completion Date

2021-07-01

Brief Summary

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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.

Detailed Description

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Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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control

no supplement will be provided on the day of the experiment

Group Type EXPERIMENTAL

satiety

Intervention Type 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

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

Group Type EXPERIMENTAL

satiety

Intervention Type 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

Dietary Supplement: Generation UCAN supplementation

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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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

Intervention Type BEHAVIORAL

Dietary Supplement: Generation UCAN supplementation

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Western University, Canada

OTHER

Sponsor Role lead

Responsible Party

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Peter Lemon

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Lemon, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Central Contacts

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Crystal Lee, BSc

Role: CONTACT

519 6612111

Manuel Manuel, MSc

Role: CONTACT

519 6612111

Other Identifiers

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116302

Identifier Type: -

Identifier Source: org_study_id

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