Weight GainNCT04069351
Body Composition Changes During Overfeeding Plus Resistance Training
A study testing High-calorie mass gainer supplement and Resistance Training in people with Weight Gain and Resistance Training, run by Texas Tech University at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Weight Gain, Resistance Training, Overeating
- What is being tested?
- High-calorie mass gainer supplement and Resistance Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2019to 26 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Weight Gain, Resistance Training, Overeating
- Being tested
- High-calorie mass gainer supplement, Resistance Training
- Medical subject headings
- Weight Gain, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-calorie mass gainer supplementDietary supplement
A high-calorie mass gainer supplement will be provided to all participants to promote weight gain.
Resistance TrainingOther
All participants will complete a 6-week supervised resistance training program.
| Study group | Role | What they receive |
|---|---|---|
| Overfeeding Plus Resistance Training Arm | Experimental | 6-week overfeeding plus resistance training arm Receives: Dietary Supplement: High-calorie mass gainer supplement; Other: Resistance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks
Rate of Body Mass Gain
Rate of body mass gained calculated in kilograms gained per week.
Measured: 6 weeks
Fat-free mass
Fat-free mass in kilograms, assessed via multiple methods.
Measured: 6 weeks
Fat mass
Fat mass in kilograms, assessed via multiple methods.
Measured: 6 weeks
Skeletal muscle size
Muscle thickness in centimeters.
Measured: 6 weeks
Resting metabolism
Resting metabolism in kcal/day.
Measured: 6 weeks
Body mass
Body mass in kilograms
Measured: 6 weeks
Secondary outcomes (5)
Muscular Strength (1-repetition maximum test)
Maximal muscular strength in kilograms as assessed by 1-repetition maximum test.
Measured: 6 weeks
Muscular Endurance (repetitions until failure)
Muscular endurance in repetitions (i.e. repetitions until failure) using a sub-maximal load.
Measured: 6 weeks
Skeletal Muscle Quality via Ultrasonography
Skeletal muscle quality via ultrasonography (e.g. echo intensity in arbitrary units).
Measured: 6 weeks
Estimated Skeletal Muscle Glycogen
Estimated muscle glycogen as assessed via ultrasound, in arbitrary units.
Measured: 6 weeks
Estimated Skeletal Muscle Intramuscular Fat
Estimated intramuscular fat as assessed via ultrasound, in arbitrary units
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start18 Sep 2019
- Primary completion26 Nov 2019
- Study completion26 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight GainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Dymatize Enterprises, LLC, MuscleSound
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069351
- Sponsor's protocol ID
- IRB2019-356
- Status last verified
- May 2020
- First submitted
- 14 Aug 2019
- Last updated
- 7 May 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 34172636
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition Changes During Overfeeding Plus Resistance Training: Influence of Rate of Mass Gain, Assessment Method, and Participant Standardization
- ClinicalTrials.gov ID
- NCT04069351
- Acronym / sponsor ID
- IRB2019-356
- Conditions
- Weight Gain, Resistance Training, Overeating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Dymatize Enterprises, LLC, MuscleSound
- Study start
- 18 Sep 2019 (actual)
- Primary completion
- 26 Nov 2019 (actual)
- Study completion
- 26 Nov 2019 (actual)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Overfeeding Plus Resistance Training Arm | Experimental | Dietary Supplement: High-calorie mass gainer supplement, Other: Resistance Training6-week overfeeding plus resistance training arm |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-calorie mass gainer supplementA high-calorie mass gainer supplement will be provided to all participants to promote weight gain. | Dietary supplement | Overfeeding Plus Resistance Training Arm |
| Resistance TrainingAll participants will complete a 6-week supervised resistance training program. | Other | Overfeeding Plus Resistance Training Arm |
Primary outcome
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).
Rate of Body Mass Gain
Time frame: 6 weeks
Rate of body mass gained calculated in kilograms gained per week.
Fat-free mass
Time frame: 6 weeks
Fat-free mass in kilograms, assessed via multiple methods.
Fat mass
Time frame: 6 weeks
Fat mass in kilograms, assessed via multiple methods.
Skeletal muscle size
Time frame: 6 weeks
Muscle thickness in centimeters.
Resting metabolism
Time frame: 6 weeks
Resting metabolism in kcal/day.
Body mass
Time frame: 6 weeks
Body mass in kilograms
5 secondary outcomes
Muscular Strength (1-repetition maximum test)
Time frame: 6 weeks
Muscular Endurance (repetitions until failure)
Time frame: 6 weeks
Skeletal Muscle Quality via Ultrasonography
Time frame: 6 weeks
Estimated Skeletal Muscle Glycogen
Time frame: 6 weeks
Estimated Skeletal Muscle Intramuscular Fat
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Derived from this study: PubMed 34172636Rodriguez 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-calorie mass gainer supplement and Resistance Training in people with Weight Gain and Resistance Training, run by Texas Tech University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Body Mass Gained as Fat-Free Mass (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04069351, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2020.