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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: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT04080102 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 84 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Determined from a multi-compartment model

Interventions

  • OTHER High Intensity Interval Training
  • DIETARY_SUPPLEMENT Essential Amino Acid
  • OTHER High intensity interval training and essential amino acid supplement

Trial Details

FieldValue
Enrollment Target 84 participants
Start Date 2019-03-01
Est. Completion 2020-01-05
Phase NA

What the finished NCT04080102 record still lists

NCT04080102 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).

The record links to 0 conditions, and to 3 interventions - of which High Intensity Interval Training is the first listed.

NCT04080102 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT04080102's enrollment target sits among peer trials

84 983rd of 2000 higher than 1,011 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04080102, the US trial registry maintained by the National Library of Medicine. NCT04080102 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.