NCT02630238

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 15, 2015

Completed
17 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

January 20, 2016

Status Verified

January 1, 2016

Enrollment Period

3 months

First QC Date

December 9, 2015

Last Update Submit

January 18, 2016

Conditions

Weight LossObesity

Keywords

ExerciseAmino Acids, Branched-Chain

Outcome Measures

Primary Outcomes (1)

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

    Body lean mass (%) will be measured using BodPod

    4 weeks & 8 weeks

Secondary Outcomes (1)

  • Fat Loss changes over 8 weeks at different time points

    4 weeks & 8 weeks

Study Arms (2)

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

Dietary Supplement: Branched-Chain Amino Acid SupplementationOther: ExerciseOther: 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

Other: PlaceboOther: ExerciseOther: Diet

Interventions

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

Branched-Chain Amino Acid group
PlaceboOTHER

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

Placebo Group
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

Branched-Chain Amino Acid groupPlacebo Group
DietOTHER

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

Branched-Chain Amino Acid groupPlacebo Group

Eligibility Criteria

Age18 Years - 25 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Research Laboratory, Western University

London, Ontario, N6A 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Weight LossObesityMotor Activity

Interventions

ExerciseDiet

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Peter Lemon, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lemon, PhD, FACSM

CONTACT

19-661-2111plemon@uwo.ca

Alicia MacDougall

CONTACT

5192002901amacdou6@uwo.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Weider Research Chair Director, Exercise Nutrition Research Laboratory

Study Record Dates

First Submitted

December 9, 2015

First Posted

December 15, 2015

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

January 20, 2016

Record last verified: 2016-01

Locations

CA(1)