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

Weight Loss Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04458493
• Other study ID #: 116302
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2020
• Est. completion date: July 1, 2021

Study information

• Verified date: July 2020
• Source: Western University, Canada
• Contact: Crystal Lee, BSc
• Phone: 519 6612111
• Email: plee263[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Overweight
• Weight Loss

Intervention

Behavioral:
• 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

Dietary Supplement:
• Dietary Supplement: Generation UCAN supplementation
meal replacement, Generation UCAN supplement, 400ml, 20% solution

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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