NCT01186536

Brief Summary

The objective of this project is to determine the effect of 9 months of progressive resistance training with daily whey protein supplements on the body composition (changes in muscle and fat) in young adults. The investigators hypothesize that those individuals who receive whey protein supplements will have larger gains in muscle and larger losses of fat tissue in response to resistance training compared to those who receive supplements of soy or carbohydrate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Jun 2007

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

June 1, 2007

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

March 26, 2010

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

November 9, 2012

Status Verified

November 1, 2012

Enrollment Period

5.1 years

First QC Date

March 26, 2010

Last Update Submit

November 7, 2012

Conditions

Keywords

Whey ProteinSoy ProteinResistance trainingWeight Management

Outcome Measures

Primary Outcomes (1)

  • Body Composition

    Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA.

    9 months

Secondary Outcomes (3)

  • 24 hour energy expenditure and substrate oxidation

    9 months

  • Muscular strength and endurance

    9 months

  • Resting Metabolic Rate

    9 months

Study Arms (3)

Whey protein supplementation

EXPERIMENTAL

Daily whey protein supplementation

Dietary Supplement: Whey Protein supplement

Soy Protein supplementation

EXPERIMENTAL

Daily soy protein supplementation

Dietary Supplement: Soy Protein Supplement

Placebo

EXPERIMENTAL

Daily carbohydrate placebo supplementation

Dietary Supplement: Carbohydrate supplement

Interventions

Whey Protein supplementDIETARY_SUPPLEMENT

40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration)

Whey protein supplementation
Soy Protein SupplementDIETARY_SUPPLEMENT

40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration)

Soy Protein supplementation
Carbohydrate supplementDIETARY_SUPPLEMENT

40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)

Placebo

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI 25-39.9
  • must be 18- 30 years old
  • sedentary
  • no medications
  • stable weight for at least 3 months

You may not qualify if:

  • Tobacco/Drug user
  • metabolism altering medication
  • gain/lost 10lbs in the last 3 months
  • current exerciser

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Energy Balance Lab, The University of Kansas

Lawrence, Kansas, 66045, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Richard A. Washburn, Ph.D.

    University of Kansas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 26, 2010

First Posted

August 23, 2010

Study Start

June 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

November 9, 2012

Record last verified: 2012-11

Locations