NCT04080102

Essential Amino Acids and High Intensity Interval Training

Completed NA Last updated 30 April 2020

What this trial tests

NA trial testing High Intensity Interval Training in Cardiovascular Risk Factor in 84 participants. Completed in 5 January 2020.

Timeline

1 March 2019

Primary endpoint
5 January 2020

5 January 2020

Quick facts

Lead sponsor	University of North Carolina, Chapel Hill
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	84
Start date	1 March 2019
Primary completion	5 January 2020
Estimated completion	5 January 2020
Sites	1 location across United States

Drugs / interventions tested

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

Conditions studied

• Cardiovascular Risk Factor — all drugs for Cardiovascular Risk Factor →
• Obesity — all drugs for Obesity →

Sponsor

University of North Carolina, Chapel Hill

Who can join

Adults 30 to 50, any sex, with Cardiovascular Risk Factor or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Metabolic effects of high-intensity interval training and essential amino acids.
   Hirsch KR, Greenwalt CE, Cabre HE, Gould LM, et al · · 2021 · cited 12× · PMID 34427732 · DOI 10.1007/s00421-021-04792-4