ObesityNCT01186536
Whey Protein, Resistance Training, and Changes in Body Composition
A study testing Whey Protein supplement, Soy Protein Supplement and Carbohydrate supplement in people with Obesity, run by University of Kansas at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Whey Protein supplement, Soy Protein Supplement and Carbohydrate supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Jul 2012
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI 25-39.9
- must be 18- 30 years old
- sedentary
- no medications
- stable weight for at least 3 months
Who cannot join
- Tobacco/Drug user
- metabolism altering medication
- gain/lost 10lbs in the last 3 months
- current exerciser
Trial locations and contacts
1 site in 1 country.
United States1 site
Energy Balance Lab, The University of Kansas
Lawrence, Kansas, 66045
About this study
Official title: Whey Protein Supp. w/ Resistance Training; Effects on Body Comp. of Young Adults.
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.
Read the detailed description
Healthy men and women will be recruited to participate in 9 months of supervised resistance training (3 days/wk) and will be randomized to one of three daily supplement groups: Whey protein, soy protein, or carbohydrate control. Body weight, muscular strength and endurance, and resting blood pressure will be assessed at baseline, 3, 6 and 9 months. Body composition will be assessed at baseline, 3, 5, 7, and 9 months. A sub-sample (N = 17 per group, assessed at baseline and 9 months) will be randomly selected for muscle samples of the upper leg to determine changes in the size of muscle fibers, and chemical factors associated with muscle growth. Blood samples will be obtained from sub-sample participants to assess changes in glucose and fat metabolism, as well as other chemicals likely to promote or inhibit muscle growth. We will also assess changes in daily energy expenditure and the use of fuel to produce energy (carbohydrate, fat, protein) that may result from the intervention. We 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.
- Conditions
- Obesity
- Being tested
- Whey Protein supplement, Soy Protein Supplement, Carbohydrate supplement
- Keywords
- Whey Protein, Soy Protein, Resistance training, Weight Management
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Protein supplementDietary supplement
40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration)
Soy Protein SupplementDietary supplement
40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration)
Carbohydrate supplementDietary supplement
40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)
| Study group | Role | What they receive |
|---|---|---|
| Whey protein supplementation | Experimental | Daily whey protein supplementation Receives: Dietary Supplement: Whey Protein supplement |
| Soy Protein supplementation | Experimental | Daily soy protein supplementation Receives: Dietary Supplement: Soy Protein Supplement |
| Placebo | Experimental | Daily carbohydrate placebo supplementation Receives: Dietary Supplement: Carbohydrate supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (3)
24 hour energy expenditure and substrate oxidation
24hr energy expenditure and substrate oxidation will be measured by whole room indirect calorimetry
Measured: 9 months
Muscular strength and endurance
One rep max strength will be measured on the chest and leg press.
Measured: 9 months
Resting Metabolic Rate
Resting metabolic rate as measured by indirect calorimetry as kcal/day will be evaluated. Also, substrate oxidation (fat and carbohydrate oxidation) will be evaluated.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJun 2007
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Collaborators
- Dairy Management Inc.
- Responsible party
- Principal investigator, Richard Washburn, University of Kansas
- Investigators
- Richard A. Washburn, Ph.D., Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186536
- Sponsor's protocol ID
- HSCL16583
- Other IDs
- DMI01425
- Status last verified
- Nov 2012
- First submitted
- 26 Mar 2010
- Last updated
- 9 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whey Protein Supp. w/ Resistance Training; Effects on Body Comp. of Young Adults.
- ClinicalTrials.gov ID
- NCT01186536
- Acronym / sponsor ID
- HSCL16583
- Conditions
- Obesity
- Keywords
- Whey Protein, Soy Protein, Resistance training, Weight Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Collaborators
- Dairy Management Inc.
- Study start
- Jun 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Aug 2010 (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.
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.
Detailed description
Healthy men and women will be recruited to participate in 9 months of supervised resistance training (3 days/wk) and will be randomized to one of three daily supplement groups: Whey protein, soy protein, or carbohydrate control. Body weight, muscular strength and endurance, and resting blood pressure will be assessed at baseline, 3, 6 and 9 months. Body composition will be assessed at baseline, 3, 5, 7, and 9 months. A sub-sample (N = 17 per group, assessed at baseline and 9 months) will be randomly selected for muscle samples of the upper leg to determine changes in the size of muscle fibers, and chemical factors associated with muscle growth. Blood samples will be obtained from sub-sample participants to assess changes in glucose and fat metabolism, as well as other chemicals likely to promote or inhibit muscle growth. We will also assess changes in daily energy expenditure and the use of fuel to produce energy (carbohydrate, fat, protein) that may result from the intervention. We 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Whey protein supplementation | Experimental | Dietary Supplement: Whey Protein supplementDaily whey protein supplementation |
| Soy Protein supplementation | Experimental | Dietary Supplement: Soy Protein SupplementDaily soy protein supplementation |
| Placebo | Experimental | Dietary Supplement: Carbohydrate supplementDaily carbohydrate placebo supplementation |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- BMI 25-39.9
- must be 18- 30 years old
- sedentary
- no medications
- stable weight for at least 3 months
Key exclusion criteria (4 listed)
- Tobacco/Drug user
- metabolism altering medication
- gain/lost 10lbs in the last 3 months
- current exerciser
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 |
|---|---|---|
| Whey Protein supplement40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration) | Dietary supplement | Whey protein supplementation |
| Soy Protein Supplement40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration) | Dietary supplement | Soy Protein supplementation |
| Carbohydrate supplement40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration) | Dietary supplement | Placebo |
Primary outcome
Body Composition
Time frame: 9 months
Changes in body composition will be evaluated by measuring the change in percent body fat, total fat mass, and total lean mass by DEXA.
3 secondary outcomes
24 hour energy expenditure and substrate oxidation
Time frame: 9 months
Muscular strength and endurance
Time frame: 9 months
Resting Metabolic Rate
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2012.
Related trials for Obesity
Not yet recruiting
Transcutaneous Auricular Vagus Nerve Stimulation Combined With Lifestyle Intervention for Visceral Fat Reduction in Adults With Overweight or Obesity
Overweight, Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
HS235 Study in Overweight and Obese Participants With Combined Pre and Post-Capillary Pulmonary Hypertension Due to Heart Failure With Preserved Ejection Fraction
Pulmonary Hypertension, Heart Failure With Preserved Ejection Fraction
Not yet recruitingPhase 3
ELEVATE-LIVER: A Study to Test Whether Survodutide Helps Improve Heart Structure and Function in People With Overweight or Obesity and Fatty Liver Disease
Obesity, Metabolic Dysfunction-associated Steatotic Liver Disease
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity
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.
Richard A. Washburn, Ph.D. principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey Protein supplement, Soy Protein Supplement and Carbohydrate supplement in people with Obesity, run by University of Kansas at 1 site in United States.
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 5 inclusion and 4 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: finished, as of the sponsor's last update on 9 Nov 2012. 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 United States. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body Composition (time frame: 9 months). 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 9 Nov 2012.