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

Study Overview
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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.

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

Conditions
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Weight Loss

Intervention / Treatment
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* Behavioral: satiety
* Dietary Supplement: Dietary Supplement: Generation UCAN supplementation


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 |