Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04069351
Status:
COMPLETED
Last Update Posted:
2020-05-07
First Post:
2019-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Body Composition Changes During Overfeeding Plus Resistance Training
Sponsor:
Texas Tech University
Organization:
Study Overview
Official Title:
Body Composition Changes During Overfeeding Plus Resistance Training: Influence of Rate of Mass Gain, Assessment Method, and Participant Standardization
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: