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Body Composition Changes During Overfeeding Plus Resistance Training

Primary Purpose

Weight Gain, Resistance Training, Overeating

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High-calorie mass gainer supplement
Resistance Training
Sponsored by
Texas Tech University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Weight Gain

Eligibility Criteria

18 Years - 40 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Texas Tech University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Overfeeding Plus Resistance Training Arm

Arm Description

6-week overfeeding plus resistance training arm

Outcomes

Primary Outcome Measures

Proportion of Body Mass Gained as Fat-Free Mass
Calculated as change in fat-free mass (in kilograms) divided by change in body mass (in kilograms).
Rate of Body Mass Gain
Rate of body mass gained calculated in kilograms gained per week.
Fat-free mass
Fat-free mass in kilograms, assessed via multiple methods.
Fat mass
Fat mass in kilograms, assessed via multiple methods.
Skeletal muscle size
Muscle thickness in centimeters.
Resting metabolism
Resting metabolism in kcal/day.
Body mass
Body mass in kilograms

Secondary Outcome Measures

Muscular Strength (1-repetition maximum test)
Maximal muscular strength in kilograms as assessed by 1-repetition maximum test.
Muscular Endurance (repetitions until failure)
Muscular endurance in repetitions (i.e. repetitions until failure) using a sub-maximal load.
Skeletal Muscle Quality via Ultrasonography
Skeletal muscle quality via ultrasonography (e.g. echo intensity in arbitrary units).
Estimated Skeletal Muscle Glycogen
Estimated muscle glycogen as assessed via ultrasound, in arbitrary units.
Estimated Skeletal Muscle Intramuscular Fat
Estimated intramuscular fat as assessed via ultrasound, in arbitrary units

Full Information

First Posted
August 14, 2019
Last Updated
May 5, 2020
Sponsor
Texas Tech University
Collaborators
Dymatize Enterprises, LLC, MuscleSound
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1. Study Identification

Unique Protocol Identification Number
NCT04069351
Brief Title
Body Composition Changes During Overfeeding Plus Resistance Training
Official Title
Body Composition Changes During Overfeeding Plus Resistance Training: Influence of Rate of Mass Gain, Assessment Method, and Participant Standardization
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
September 18, 2019 (Actual)
Primary Completion Date
November 26, 2019 (Actual)
Study Completion Date
November 26, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Texas Tech University
Collaborators
Dymatize Enterprises, LLC, MuscleSound

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Weight Gain, Resistance Training, Overeating

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Overfeeding Plus Resistance Training Arm
Arm Type
Experimental
Arm Description
6-week overfeeding plus resistance training arm
Intervention Type
Dietary Supplement
Intervention Name(s)
High-calorie mass gainer supplement
Intervention Description
A high-calorie mass gainer supplement will be provided to all participants to promote weight gain.
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
All participants will complete a 6-week supervised resistance training program.
Primary Outcome Measure Information:
Title
Proportion of Body Mass Gained as Fat-Free Mass
Description
Calculated as change in fat-free mass (in kilograms) divided by change in body mass (in kilograms).
Time Frame
6 weeks
Title
Rate of Body Mass Gain
Description
Rate of body mass gained calculated in kilograms gained per week.
Time Frame
6 weeks
Title
Fat-free mass
Description
Fat-free mass in kilograms, assessed via multiple methods.
Time Frame
6 weeks
Title
Fat mass
Description
Fat mass in kilograms, assessed via multiple methods.
Time Frame
6 weeks
Title
Skeletal muscle size
Description
Muscle thickness in centimeters.
Time Frame
6 weeks
Title
Resting metabolism
Description
Resting metabolism in kcal/day.
Time Frame
6 weeks
Title
Body mass
Description
Body mass in kilograms
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Muscular Strength (1-repetition maximum test)
Description
Maximal muscular strength in kilograms as assessed by 1-repetition maximum test.
Time Frame
6 weeks
Title
Muscular Endurance (repetitions until failure)
Description
Muscular endurance in repetitions (i.e. repetitions until failure) using a sub-maximal load.
Time Frame
6 weeks
Title
Skeletal Muscle Quality via Ultrasonography
Description
Skeletal muscle quality via ultrasonography (e.g. echo intensity in arbitrary units).
Time Frame
6 weeks
Title
Estimated Skeletal Muscle Glycogen
Description
Estimated muscle glycogen as assessed via ultrasound, in arbitrary units.
Time Frame
6 weeks
Title
Estimated Skeletal Muscle Intramuscular Fat
Description
Estimated intramuscular fat as assessed via ultrasound, in arbitrary units
Time Frame
6 weeks

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Texas Tech University
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79409
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34172636
Citation
Rodriguez C, Harty PS, Stratton MT, Siedler MR, Smith RW, Johnson BA, Dellinger JR, Williams AD, White SJ, Benavides ML, Tinsley GM. Comparison of Indirect Calorimetry and Common Prediction Equations for Evaluating Changes in Resting Metabolic Rate Induced by Resistance Training and a Hypercaloric Diet. J Strength Cond Res. 2022 Nov 1;36(11):3093-3104. doi: 10.1519/JSC.0000000000004077. Epub 2021 Jun 22.
Results Reference
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Body Composition Changes During Overfeeding Plus Resistance Training

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