NCT04069351

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

September 18, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2019

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

2 months

First QC Date

August 14, 2019

Last Update Submit

May 5, 2020

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • Rate of Body Mass Gain

    Rate of body mass gained calculated in kilograms gained per week.

    6 weeks

  • Fat-free mass

    Fat-free mass in kilograms, assessed via multiple methods.

    6 weeks

  • Fat mass

    Fat mass in kilograms, assessed via multiple methods.

    6 weeks

  • Skeletal muscle size

    Muscle thickness in centimeters.

    6 weeks

  • Resting metabolism

    Resting metabolism in kcal/day.

    6 weeks

  • Body mass

    Body mass in kilograms

    6 weeks

Secondary Outcomes (5)

  • Muscular Strength (1-repetition maximum test)

    6 weeks

  • Muscular Endurance (repetitions until failure)

    6 weeks

  • Skeletal Muscle Quality via Ultrasonography

    6 weeks

  • Estimated Skeletal Muscle Glycogen

    6 weeks

  • Estimated Skeletal Muscle Intramuscular Fat

    6 weeks

Study Arms (1)

Overfeeding Plus Resistance Training Arm

EXPERIMENTAL

6-week overfeeding plus resistance training arm

Dietary Supplement: High-calorie mass gainer supplementOther: Resistance Training

Interventions

A high-calorie mass gainer supplement will be provided to all participants to promote weight gain.

Overfeeding Plus Resistance Training Arm

All participants will complete a 6-week supervised resistance training program.

Overfeeding Plus Resistance Training Arm

Eligibility Criteria

Age18 Years - 40 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Tech University

Lubbock, Texas, 79409, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Weight GainHyperphagia

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Body Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSigns and Symptoms, Digestive

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2019

First Posted

August 28, 2019

Study Start

September 18, 2019

Primary Completion

November 26, 2019

Study Completion

November 26, 2019

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations