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Weight LossNCT02630238

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

A study testing Branched-Chain Amino Acid Supplementation, Exercise and Diet in people with Weight Loss and Obesity, run by University of Western Ontario, Canada at 1 site in Canada.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 25 years, women onlyHealthy volunteers can take part
Conditions the study is for
Weight Loss, Obesity
What is being tested?
Branched-Chain Amino Acid Supplementation, Exercise and Diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteCanada
Study dates
Jan 2016to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 25 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Peter Lemon, PhD, FACSM contact

19-661-2111 ext. 88139

plemon@uwo.ca

Alicia MacDougall contact

5192002901

amacdou6@uwo.ca

Canada1 site, 1 recruiting
  • Exercise Nutrition Research Laboratory, Western University

    London, Ontario, N6A 3K7

    Peter Lemon, PhD, 519 661 2111 ext. 88139, plemon@uwo.ca

    Peter Lemon, PhD

    Recruiting

Other trials in Canada

About this study

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.

Read the 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
Being tested
Branched-Chain Amino Acid Supplementation, Placebo, Exercise, Diet
Keywords
Exercise, Amino Acids, Branched-Chain
Medical subject headings
Weight Loss, Obesity, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Branched-Chain Amino Acid SupplementationDietary 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

  • PlaceboOther

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

  • ExerciseOther

    Exercise will take place in a class based, circuit training setting run by a certified personal trainer composed of both aerobic and lifting exercises

  • DietOther

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

Study groups in NCT02630238
Study groupRoleWhat they receive
Branched-Chain Amino Acid groupExperimentalThe 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
Receives: Dietary Supplement: Branched-Chain Amino Acid Supplementation; Other: Exercise; Other: Diet
Placebo GroupPlacebo comparatorThe placebo will be on a hypocaloric diet, exercise and receive isoenergetic beverage with carbohydrate instead of branched-chain amino acids
Receives: Other: Placebo; Other: Exercise; Other: Diet

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Measuring changes in Lean Mass over 8 weeks at different time points

    Body lean mass (%) will be measured using BodPod

    Measured: 4 weeks & 8 weeks

Secondary outcomes (1)
  1. Fat Loss changes over 8 weeks at different time points

    Body fat loss (%) will be measured using BodPod

    Measured: 4 weeks & 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2015 (estimated)
  2. Study startJan 2016
  3. Primary completionApr 2016 (estimated)
  4. Study completionApr 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02630238
Sponsor's protocol ID
10009692
Status last verified
Jan 2016
First submitted
9 Dec 2015
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Branched-Chain Amino Acid Supplementation, Exercise and Diet in people with Weight Loss and Obesity, run by University of Western Ontario, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peter Lemon, PhD, FACSM (19-661-2111 ext. 88139, plemon@uwo.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measuring changes in Lean Mass over 8 weeks at different time points (time frame: 4 weeks & 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.

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