The Effect of Branched-Chain Amino Acid Supplementation and Exercise on Body Composition During Energy Restriction

Obesity Clinical Trial

Official title:

The Effect of Branched-Chain Amino Acid Supplementation and Exercise on Body Composition During Energy Restriction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02630238
• Other study ID #: 10009692
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2015
• Last updated: January 18, 2016
• Start date: January 2016
• Est. completion date: April 2016

Study information

• Verified date: January 2016
• Source: University of Western Ontario, Canada
• Contact: Peter Lemon, PhD, FACSM
• Phone: 19-661-2111
• Email: plemon[@]uwo.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This double blind placebo study will take place over an 8 week treatment period of diet and exercise. All participants (n=16), in two groups, will be placed on the same hypocaloric diet and exercise program. Participants will be matched into pairs based on body fat % and then assigned into a test group & a placebo group. The placebo will be in the form of a powdered isoenergetic beverage with carbohydrate similar in taste & appearance to the powder BCAA supplement that the test group will receive. The test group will be put on 0.342g/kg of BCAA per day, partially accounted for through their diet with the rest provided by a BCAA supplement. At baseline, 4 weeks and 8 weeks habitual 3 day food logs, waist to hip ratio and BodPod measures of body fat & lean mass (both percentage & absolute values) will be taken for all participants.

Description:

This double blind placebo study will take place over an 8 week treatment period of diet and exercise. All participants (n=16) will be placed on the same hypocaloric diet and exercise program. Both groups will exercise at the same time. Baseline habitual 3 day food logs, waist to hip ratio and BodPod measures of body fat & lean mass (both percentage & absolute values) will be taken for all participants. Each will be provided with macronutrient guidelines to follow (40% carbohydrate, 30% protein, 30% fat) & placed on a daily energy deficit of 500 calories for the 8 week study period. Participants in both treatment and control groups will be asked to record their dietary intake using the MyFitnessPal smartphone application or website in order to insure compliance to the prescribed diet. MyFitnessPal is a fast and easy to use calorie counter for Windows or phones. Further, it has the largest food database of any calorie counter apps (over 3,000,000 foods). Each individual will provide the investigators with a weekly screen shot of their mean data. Exercise will take place in a class based, circuit training setting run by a certified personal trainer (Alicia MacDougall). Exercise safety will be assessed by a Physical Readiness Questionnaire (the Par- Q and You - see appendix). Further, it is important to note that these women are overweight, not obese, and that research evidence indicates clearly that inactivity is far more hazardous to one's health than regular exercise (American College of Sports Medicine). Attendance will be recorded to document adherence. This style of training was chosen in order to combine both strength and endurance based training in an attempt to generate fat loss while keeping the workouts controlled by study investigators. Participants will be matched into pairs based on body fat % and then assigned into a test group & a placebo group. This ensures the groups will have similar mean and SD for fat mass at baseline. The placebo group will follow the diet and exercise regime described above plus, be given an isoenergetic placebo to take daily. The placebo will be in the form of a powdered isoenergetic beverage with carbohydrate instead of amino acids, similar in taste & appearance to the powder BCAA supplement that the test group will receive in order to keep the participants blind to their treatment. Specifically, the test group 0.342g/kg of BCAA per day, partially accounted for through their diet with the rest provided by a BCAA supplement (NOW BCAA Powder). The supplement will provide a 2:1:1 ratio of leucine, isoleucine, & valine respectively. At 4 and 8 week of treatment, all participants will be remeasured for waist to hip ratio and BodPod measures of body fat & lean mass. These values can then be compared to the baseline values for each of the study groups in order to determine if the increased BCAA intake proved to be effective. The beverage powder (both treatment & placebo) will be distributed in zip lock plastic bags to the participants by a third party (a graduate student) not involved in the study thereby keeping the investigators blind.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 25 Years

Eligibility

Inclusion Criteria:

• Healthy, sedentary, overweight (BMI 25-29.9) females, between the ages of 18 - 25 years. Men will need to be measured in a separate study as there are likely gender differences and as this is an undergraduate student project there is insufficient time to assess both.

Exclusion Criteria:

• Women who are; unhealthy, currently physically active, taking medications, have health conditions contraindicated participation in exercise, allergic to milk, pregnant, or breastfeeding will be excluded.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Dietary Supplement:
• Branched-Chain Amino Acid Supplementation
All participants will partake in the same diet & exercise regime but this group will also be placed on a BCAA intake level of 0.342g/kg of BCAA per day

Other:
• Placebo
All participants will partake in the same diet & exercise regime but this group will receive an isocaloric placebo in form of carbohydrate solution
• Exercise
Exercise will take place in a class based, circuit training setting run by a certified personal trainer composed of both aerobic and lifting exercises
• Diet
Each participants will be placed on a daily energy deficit of 500 calories for the 8 week study period.

Locations

Country	Name	City	State
Canada	Exercise Nutrition Research Laboratory, Western University	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University of Western Ontario, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring changes in Lean Mass over 8 weeks at different time points	Body lean mass (%) will be measured using BodPod	4 weeks & 8 weeks	No
Secondary	Fat Loss changes over 8 weeks at different time points	Body fat loss (%) will be measured using BodPod	4 weeks & 8 weeks	No