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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
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Loss

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

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

    First Posted
    June 29, 2020
    Last Updated
    July 28, 2020
    Sponsor
    Western University, Canada
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    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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