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NCT04080102 · ClinicalTrials.gov registry record · NA
Essential Amino Acids and High Intensity Interval Training
A NA study, sponsored by University of North Carolina, Chapel Hill.
- Completed
- Registry status
- NA
- Development phase
- 84
- Enrollment target
NCT04080102 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 84 participants.
The verdict
NCT04080102, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.
- COMPLETED
- Registry status
- NA
- Development phase
- 84 participants
- Enrollment target
Study Summary
Purpose: The primary purpose is to determine the combined effects of essential amino acids (EAA) supplementation and high intensity interval training (HIIT) on body composition, muscle characteristics, and muscle architecture in overweight men and women over the course of eight weeks. A secondary purpose is to determine the metabolic effects of EAA supplementation and HIIT on whole body protein turnover, metabolic rate, substrate metabolism, and metabolomics. A tertiary purpose is to evaluate the modulatory effects of sex on body composition, metabolism, metabolic profile, cardiorespiratory fitness, and hunger and satiety in response to EAA supplementation and HIIT. Participants: Healthy overweight and obese men and women (30-50 years) Procedures (methods): In a block randomized design, 78 healthy, overweight or obese men and women will be randomized, to one of four, eight-week intervention groups using a 2:2:2:1 group allocation design: 1) essential amino acids (EAA) supplementation (7.2 grams EAA daily); 2) HIIT, two days per week of cycle ergometry training; 3) EAA + HIIT; or 4) control (CON), receiving no intervention. Measurements of body composition, muscle characteristics, resting metabolic rate, substrate metabolism, and cardiorespiratory fitness will be measured at baseline, 4-weeks, and 8-weeks. Metabolomics and whole body protein turnover will also be measured at baseline and 8-weeks. Subjects will be asked to arrive to testing sessions following a 12 hour fast (except for water), consuming no food, caffeine, or alcohol. Participants will also be asked to abstain from physical activity for 24 hours prior to testing. Subjects will complete one electronic contact (phone/email screening) and up to 22 in-person sessions (enrollment; 5 testing sessions \[2 at base, 1 at 4week, 2 at 8week\]; 16 training sessions \[for HIIT and EAA+HIIT\]) over the course of 8 weeks.
Interventions
- OTHER High Intensity Interval Training
- DIETARY_SUPPLEMENT Essential Amino Acid
- OTHER High intensity interval training and essential amino acid supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2019-03-01 |
| Est. Completion | 2020-01-05 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04080102
The ClinicalTrials.gov registry entry for NCT04080102 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of North Carolina, Chapel Hill, which has 1,109 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which High Intensity Interval Training is the first listed.
NCT04080102 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04080102 about?
NCT04080102 is a clinical study titled "Essential Amino Acids and High Intensity Interval Training". Purpose: The primary purpose is to determine the combined effects of essential amino acids (EAA) supplementation and high intensity interval training (HIIT) on body composition, muscle characteristics, and muscle architecture in overweight men and women over the course of eight weeks. A secondary pu...
What is the current status of trial NCT04080102?
This trial is currently completed. It is a NA study. The enrollment target is 84 participants. The study started on 2019-03-01. Estimated completion is 2020-01-05.
What interventions are being tested in trial NCT04080102?
The interventions under investigation include: High Intensity Interval Training (OTHER), Essential Amino Acid (DIETARY_SUPPLEMENT), High intensity interval training and essential amino acid supplement (OTHER).
Who is sponsoring clinical trial NCT04080102?
This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.
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