Essential Amino Acids and High Intensity Interval Training

April 29, 2020 updated by: University of North Carolina, Chapel Hill

Metabolic Effects of 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 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Applied Physiology Laboratory, Fetzer Hall Room 25

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Fat Free Mass (kg)
Time Frame: 8 weeks
Determined from a multi-compartment model
8 weeks
Fat mass (kg)
Time Frame: 8 weeks
Determined from a multi-compartment model
8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Muscle cross sectional area (cm3)
Time Frame: 8 weeks
Determined from ultrasound
8 weeks
Echo intensity (a.u.)
Time Frame: 8 weeks
Determined from ultrasound
8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Metabolic rate (kcal/day)
Time Frame: 8 weeks
resting metabolic rate from indirect calorimetry
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Strength and Conditioning Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Abbie Smith-Ryan, PhD, University of North Carolina, Chapel Hill
  • Principal Investigator: Katie Hirsch, MA, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 5, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 5, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 26, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 3, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 18-2726

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with University of North Carolina (UNC).

IPD Sharing Time Frame

Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication.

IPD Sharing Access Criteria

An investigator who proposes to use the data must have approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and execute a data use/sharing agreement with UNC.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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