Body Composition Changes During Overfeeding Plus Resistance Training

Weight Gain Clinical Trial

Official title:

Body Composition Changes During Overfeeding Plus Resistance Training: Influence of Rate of Mass Gain, Assessment Method, and Participant Standardization

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04069351
• Other study ID #: IRB2019-356
• Status: Completed
• Phase: N/A
• Start date: September 18, 2019
• Est. completion date: November 26, 2019

Study information

• Verified date: May 2020
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: November 26, 2019
• Est. primary completion date: November 26, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Hyperphagia
• Overeating
• Resistance Training
• Weight Gain

Intervention

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.

Locations

Country	Name	City	State
United States	Texas Tech University	Lubbock	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Texas Tech University	Dymatize Enterprises, LLC, MuscleSound

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	6 weeks
Primary	Rate of Body Mass Gain	Rate of body mass gained calculated in kilograms gained per week.	6 weeks
Primary	Fat-free mass	Fat-free mass in kilograms, assessed via multiple methods.	6 weeks
Primary	Fat mass	Fat mass in kilograms, assessed via multiple methods.	6 weeks
Primary	Skeletal muscle size	Muscle thickness in centimeters.	6 weeks
Primary	Resting metabolism	Resting metabolism in kcal/day.	6 weeks
Primary	Body mass	Body mass in kilograms	6 weeks
Secondary	Muscular Strength (1-repetition maximum test)	Maximal muscular strength in kilograms as assessed by 1-repetition maximum test.	6 weeks
Secondary	Muscular Endurance (repetitions until failure)	Muscular endurance in repetitions (i.e. repetitions until failure) using a sub-maximal load.	6 weeks
Secondary	Skeletal Muscle Quality via Ultrasonography	Skeletal muscle quality via ultrasonography (e.g. echo intensity in arbitrary units).	6 weeks
Secondary	Estimated Skeletal Muscle Glycogen	Estimated muscle glycogen as assessed via ultrasound, in arbitrary units.	6 weeks
Secondary	Estimated Skeletal Muscle Intramuscular Fat	Estimated intramuscular fat as assessed via ultrasound, in arbitrary units	6 weeks