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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
32

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Overfeeding Plus Resistance Training Arm
6-week overfeeding plus resistance training arm
Dietary supplement: High-calorie mass gainer supplement
A high-calorie mass gainer supplement will be provided to all participants to promote weight gain.
Other: Resistance Training
All participants will complete a 6-week supervised resistance training program.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas Tech University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Dymatize Enterprises, LLC
MuscleSound

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.

General Publications

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 18, 2019

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 26, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 26, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 7, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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