Essential Amino Acids and High Intensity Interval Training

Sponsor
University of North Carolina, Chapel Hill (Other)
Overall Status
Completed
CT.gov ID
NCT04080102
Collaborator
National Strength and Conditioning Foundation (Other)
84
1
4
10.2
8.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: High Intensity Interval Training
  • Dietary Supplement: Essential Amino Acid
  • Other: High intensity interval training and essential amino acid supplement
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Metabolic Effects of Essential Amino Acids and High-intensity Interval Training
Actual Study Start Date :
Mar 1, 2019
Actual Primary Completion Date :
Jan 5, 2020
Actual Study Completion Date :
Jan 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: High intensity interval training (HIIT)

Other: High Intensity Interval Training
Exercise

Experimental: Essential Amino Acid Supplement

Dietary Supplement: Essential Amino Acid
Oral ingestion of a powdered dietary supplement

Experimental: High intensity interval training + Essential Amino Acid

Other: High intensity interval training and essential amino acid supplement
Exercise and dietary supplement

No Intervention: Control

Outcome Measures

Primary Outcome Measures

  1. Fat Free Mass (kg) [8 weeks]

    Determined from a multi-compartment model

  2. Fat mass (kg) [8 weeks]

    Determined from a multi-compartment model

Secondary Outcome Measures

  1. Muscle cross sectional area (cm3) [8 weeks]

    Determined from ultrasound

  2. Echo intensity (a.u.) [8 weeks]

    Determined from ultrasound

Other Outcome Measures

  1. Metabolic rate (kcal/day) [8 weeks]

    resting metabolic rate from indirect calorimetry

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Men and women (25-50 years).

  • Overweight and obese: body mass index (BMI) of 27 - 40 kg·m-2 and/or percent body fat

25% for men, and BMI of 25 - 40 kg·m-2 and/or Percent Body Fat > 30% for women.

  • Healthy, non-smokers.

  • Women: eumenorrheic, reporting consistent menstruation, having 3 regular cycles in the 3 months prior to enrollment, and not pregnant or planning on becoming pregnant.

Exclusion Criteria:
  • Have current and/or history of cardiovascular disease, diabetes, metabolic, thyroid, pulmonary, renal, hepatic, gastrointestinal, musculoskeletal disorders or medical or surgical events, such as bariatric surgery, heart surgery, or any joint or musculoskeletal surgeries occurring in the 6-months prior to enrollment, that may significantly influence study outcomes or prevent safe participation.

  • Have uncontrolled hypertension or an abnormal electrocardiogram.

  • Have a diagnosed mental disorder

  • Inconsistently taking medications or taking medications that may influence study outcomes.

  • Participating in more than 150 minutes per week of moderate exercise, more than 2 days per week of resistance training, or currently participating in high intensity interval training or participated in HIIT within the previous 12 weeks.

  • Lost or gained greater than eight pounds within three months prior to the enrollment.

  • Currently consuming a high protein diet (,1.6 g·kg-1·day-1 and <25% of calories from protein).

  • Currently consuming meal replacements or dietary supplements that may taurine, or beta-hydroxy beta-methylbutyrate) within eight weeks prior to the enrollment date.

  • Reports any known sensitivity to the Essential Amino Acid treatment.

  • Has participated in another clinical trial within four weeks prior to enrollment that in the opinion of the PI would influence the results.

  • Has severely impaired hearing or speech or inability to speak English.

  • Unwilling or unable to comply with the study protocol, including abstaining from, caffeine, tobacco, alcohol, and physical activity before testing days.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Applied Physiology Laboratory, Fetzer Hall Room 25 Chapel Hill North Carolina United States 27599

Sponsors and Collaborators

  • University of North Carolina, Chapel Hill
  • National Strength and Conditioning Foundation

Investigators

  • Study Director: Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Katie Hirsch, MA, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier:
NCT04080102
Other Study ID Numbers:
  • 18-2726
First Posted:
Sep 6, 2019
Last Update Posted:
Apr 30, 2020
Last Verified:
Apr 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Apr 30, 2020