- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02630238
The Effect of Branched-Chain Amino Acid Supplementation and Exercise on Body Composition During Energy Restriction
January 18, 2016 updated by: Peter Lemon, University of Western Ontario, Canada
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Peter Lemon, PhD, FACSM
- Phone Number: 88139 19-661-2111
- Email: plemon@uwo.ca
Study Contact Backup
- Name: Alicia MacDougall
- Phone Number: 5192002901
- Email: amacdou6@uwo.ca
Study Locations
-
-
Ontario
-
London, Ontario, Canada, N6A 3K7
- Recruiting
- Exercise Nutrition Research Laboratory, Western University
-
Principal Investigator:
- Peter Lemon, PhD
-
Contact:
- Peter Lemon, PhD
- Phone Number: 88139 519 661 2111
- Email: plemon@uwo.ca
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
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 will take place in a class based, circuit training setting run by a certified personal trainer composed of both aerobic and lifting exercises
Each participants will be placed on a daily energy deficit of 500 calories for the 8 week study period.
|
Placebo Comparator: Placebo Group
The placebo will be on a hypocaloric diet, exercise and receive isoenergetic beverage with carbohydrate instead of branched-chain amino acids
|
Exercise will take place in a class based, circuit training setting run by a certified personal trainer composed of both aerobic and lifting exercises
Each participants will be placed on a daily energy deficit of 500 calories for the 8 week study period.
All participants will partake in the same diet & exercise regime but this group will receive an isocaloric placebo in form of carbohydrate solution
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Measuring changes in Lean Mass over 8 weeks at different time points
Time Frame: 4 weeks & 8 weeks
|
Body lean mass (%) will be measured using BodPod
|
4 weeks & 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fat Loss changes over 8 weeks at different time points
Time Frame: 4 weeks & 8 weeks
|
Body fat loss (%) will be measured using BodPod
|
4 weeks & 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2016
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
April 1, 2016
Study Registration Dates
First Submitted
December 9, 2015
First Submitted That Met QC Criteria
December 10, 2015
First Posted (Estimate)
December 15, 2015
Study Record Updates
Last Update Posted (Estimate)
January 20, 2016
Last Update Submitted That Met QC Criteria
January 18, 2016
Last Verified
January 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10009692
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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