Clinical trial NCT04458493: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Weight Loss
Lead sponsor: Western University, Canada
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: changes in body weight
timeFrame: 1 day prior to the start of the experiment and on the 31st day of the experiment
Secondary outcomes:
measure: changes in waist and hip circumferences
timeFrame: 1 day prior to the start of the experiment and on the 31st day of the experiment
measure: changes in fasted blood glucose
timeFrame: 1 day prior to the start of the experiment and on the 31st day of the experiment
measure: changes in appetite ratings
timeFrame: 30, 60 and 120 minutes after each meal replacement drink
measure: changes in desire to eat ratings
timeFrame: 30, 60 and 120 minutes after each meal replacement drink
Other outcomes:
Locations:
Study officials:
affiliation: Western University
name: Peter Lemon, PhD
role: PRINCIPAL_INVESTIGATOR
References: