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

NCT ID: NCT02630238

Last Updated: 2016-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2016-04-30

Brief 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.

Detailed 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.

Conditions

Weight Loss; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: DOUBLE

Study Groups

Branched-Chain Amino Acid group

The branched-chain amino acid group will be on a hypocaloric diet, exercise and receive 0.342g/kg of BCAA per day, partially accounted for through their diet with the rest provided by a BCAA supplement

Group Type: EXPERIMENTAL

Branched-Chain Amino Acid Supplementation

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise

Intervention Type: OTHER

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

Intervention Type: OTHER

Each participants will be placed on a daily energy deficit of 500 calories for the 8 week study period.

Placebo Group

The placebo will be on a hypocaloric diet, exercise and receive isoenergetic beverage with carbohydrate instead of branched-chain amino acids

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

All participants will partake in the same diet \& exercise regime but this group will receive an isocaloric placebo in form of carbohydrate solution

Exercise

Intervention Type: OTHER

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

Intervention Type: OTHER

Each participants will be placed on a daily energy deficit of 500 calories for the 8 week study period.

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

All participants will partake in the same diet \& exercise regime but this group will receive an isocaloric placebo in form of carbohydrate solution

Intervention Type: OTHER

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

Intervention Type: OTHER

Diet

Each participants will be placed on a daily energy deficit of 500 calories for the 8 week study period.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Western Ontario, Canada

OTHER

Sponsor Role: lead

Responsible Party

Peter Lemon

Professor & Weider Research Chair Director, Exercise Nutrition Research Laboratory

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter Lemon, PhD

Role: PRINCIPAL_INVESTIGATOR

Western University

Locations

Exercise Nutrition Research Laboratory, Western University

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Peter Lemon, PhD, FACSM

Role: CONTACT

plemon@uwo.ca

19-661-2111 ext. 88139

Alicia MacDougall

Role: CONTACT

amacdou6@uwo.ca

5192002901

Facility Contacts

Peter Lemon, PhD

Role: primary

plemon@uwo.ca

519 661 2111 ext. 88139

Other Identifiers

10009692

Identifier Type: -

Identifier Source: org_study_id