- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069351
Body Composition Changes During Overfeeding Plus Resistance Training
May 5, 2020 updated by: Texas Tech University
Body Composition Changes During Overfeeding Plus Resistance Training: Influence of Rate of Mass Gain, Assessment Method, and Participant Standardization
This study will examine the relationship between the rate and composition of mass gain during overfeeding plus resistance training, investigate the validity of multiple assessment methods for quantifying body composition changes during this period, and evaluate the effects of subject presentation on the interpretation of body composition changes.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This study will examine the relationship between the rate and composition of mass gain during overfeeding plus resistance training, investigate the validity of multiple assessment methods for quantifying body composition changes during this period, and evaluate the effects of subject presentation on the interpretation of body composition changes.
For this study, resistance-trained males between the ages of 18 and 40 will be recruited.
At baseline, participants will complete body composition and metabolism assessments after an overnight period of fasting and resting (i.e.
standardized conditions).
These baseline assessments will be repeated in the afternoon of the same day after a period of ad libitum physical activity and dietary intake (i.e.
non-standardized conditions).
At both visits, body composition will be evaluated by a criterion 4-compartment model, necessitating assessments via dual-energy x-ray absorptiometry, air displacement plethysmography, and bioimpedance spectroscopy.
Additional assessments will be conducted using single- and multi-frequency bioelectrical impedance analysis, infrared 3-dimensional scanning, and ultrasonography.
At a separate baseline session, muscular performance will be measured via 1-repetition maximum and repetitions-to-failure tests on the barbell bench press and plate-loaded hip sled.
Once baseline assessments are completed, participants will commence a 6-week, 3-days/week, full-body, progressive resistance training intervention in conjunction with overfeeding.
During the intervention, participants will be asked to maintain their habitual diet while also consuming a high-calorie protein/carbohydrate supplement designed to promote mass gain.
Dietary recommendations to promote adequate protein intake for maximal fat-free mass accretion will also be provided.
For all participants, a target mass gain of 1+ pounds per week will be implemented.
However, due to known variability in the propensity to gain body mass during overfeeding and resistance training, it is expected that natural variability in the actual mass gained will be present at the conclusion of the study.
After the overfeeding plus resistance training intervention is completed, participants will complete three post-intervention research visits, which will be identical to the baseline visits.
Appropriate statistical methods will be used to address the specific aims of this project.
These will include linear regression analysis, paired-samples t-tests, effect size calculations, and validity evaluation through metrics such as the constant error, total error, standard error of the estimate, and 95% limits of agreement.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79409
- Texas Tech University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Between the ages of 18 and 40
- Male
- Generally healthy (defined as an absence of any disease or medical condition which could potentially be impacted by study participation, including but not limited to cardiac, musculoskeletal, pulmonary, renal, immunological, or metabolic diseases)
- Weight-stable (defined as no change in body mass >5 pounds [2.3 kg] in the past 3 months)
- Willingness to adhere to study protocol, particularly the completion of the supervised resistance training program and consumption of dietary supplements
- Desire and/or willingness to attempt to gain body mass as part of study intervention
- Resistance trained (defined as performance of resistance training on 2 to 5 days for at least 6 months prior to study initiation), as well as meeting the objective criteria below
- Maximal strength > 1.0 x body mass on the barbell bench press exercise, executed with proper form
- Maximal strength > 2.0 x body mass on plate-loaded hip sled, executed with proper form
Exclusion Criteria:
- Failing to meet any of the aforementioned inclusion criteria
- Height greater than 75.5 inches (due to height limitation of DXA scanner)
- Weight greater than 350 pounds (due to weight limitation of DXA scanner)
- Beard longer than ½ inch (and unwillingness to shave) due to the impact of facial hair on Bod Pod body volume estimates
- History of anabolic-androgenic steroid use, based on self-report
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Overfeeding Plus Resistance Training Arm
6-week overfeeding plus resistance training arm
|
A high-calorie mass gainer supplement will be provided to all participants to promote weight gain.
All participants will complete a 6-week supervised resistance training program.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Proportion of Body Mass Gained as Fat-Free Mass
Time Frame: 6 weeks
|
Calculated as change in fat-free mass (in kilograms) divided by change in body mass (in kilograms).
|
6 weeks
|
|
Rate of Body Mass Gain
Time Frame: 6 weeks
|
Rate of body mass gained calculated in kilograms gained per week.
|
6 weeks
|
|
Fat-free mass
Time Frame: 6 weeks
|
Fat-free mass in kilograms, assessed via multiple methods.
|
6 weeks
|
|
Fat mass
Time Frame: 6 weeks
|
Fat mass in kilograms, assessed via multiple methods.
|
6 weeks
|
|
Skeletal muscle size
Time Frame: 6 weeks
|
Muscle thickness in centimeters.
|
6 weeks
|
|
Resting metabolism
Time Frame: 6 weeks
|
Resting metabolism in kcal/day.
|
6 weeks
|
|
Body mass
Time Frame: 6 weeks
|
Body mass in kilograms
|
6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscular Strength (1-repetition maximum test)
Time Frame: 6 weeks
|
Maximal muscular strength in kilograms as assessed by 1-repetition maximum test.
|
6 weeks
|
|
Muscular Endurance (repetitions until failure)
Time Frame: 6 weeks
|
Muscular endurance in repetitions (i.e.
repetitions until failure) using a sub-maximal load.
|
6 weeks
|
|
Skeletal Muscle Quality via Ultrasonography
Time Frame: 6 weeks
|
Skeletal muscle quality via ultrasonography (e.g.
echo intensity in arbitrary units).
|
6 weeks
|
|
Estimated Skeletal Muscle Glycogen
Time Frame: 6 weeks
|
Estimated muscle glycogen as assessed via ultrasound, in arbitrary units.
|
6 weeks
|
|
Estimated Skeletal Muscle Intramuscular Fat
Time Frame: 6 weeks
|
Estimated intramuscular fat as assessed via ultrasound, in arbitrary units
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 18, 2019
Primary Completion (ACTUAL)
November 26, 2019
Study Completion (ACTUAL)
November 26, 2019
Study Registration Dates
First Submitted
August 14, 2019
First Submitted That Met QC Criteria
August 23, 2019
First Posted (ACTUAL)
August 28, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 7, 2020
Last Update Submitted That Met QC Criteria
May 5, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB2019-356
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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