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.
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.
Canada1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| Branched-Chain Amino Acid group | Experimental | 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 Receives: Dietary Supplement: Branched-Chain Amino Acid Supplementation; Other: Exercise; Other: Diet |
| Placebo Group | Placebo comparator | The 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.
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)
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.
- First posted15 Dec 2015 (estimated)
- Study startJan 2016
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Western Ontario, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Lemon, University of Western Ontario, Canada
- Investigators
- Peter Lemon, PhD, Principal investigator, Western University
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
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Branched-Chain Amino Acid Supplementation and Exercise on Body Composition During Energy Restriction
- ClinicalTrials.gov ID
- NCT02630238
- Acronym / sponsor ID
- 10009692
- Conditions
- Weight Loss, Obesity
- Keywords
- Exercise, Amino Acids, Branched-Chain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of Western Ontario, CanadaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 15 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Branched-Chain Amino Acid group | Experimental | Dietary Supplement: Branched-Chain Amino Acid Supplementation, Other: Exercise, Other: DietThe 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 |
| Placebo Group | Placebo comparator | Other: Placebo, Other: Exercise, Other: DietThe placebo will be on a hypocaloric diet, exercise and receive isoenergetic beverage with carbohydrate instead of branched-chain amino acids |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Branched-Chain Amino Acid SupplementationAll 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 | Dietary supplement | Branched-Chain Amino Acid group |
| PlaceboAll participants will partake in the same diet \& exercise regime but this group will receive an isocaloric placebo in form of carbohydrate solution | Other | Placebo Group |
| ExerciseExercise will take place in a class based, circuit training setting run by a certified personal trainer composed of both aerobic and lifting exercises | Other | Branched-Chain Amino Acid group, Placebo Group |
| DietEach participants will be placed on a daily energy deficit of 500 calories for the 8 week study period. | Other | Branched-Chain Amino Acid group, Placebo Group |
Primary outcome
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
1 secondary outcome
Fat Loss changes over 8 weeks at different time points
Time frame: 4 weeks & 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Lemon, PhD principal investigator
Western University
1 site in 1 country: see every site and its status.
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.