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Cardiovascular Risk FactorNCT04080102

Essential Amino Acids and High Intensity Interval Training

A study testing High Intensity Interval Training, Essential Amino Acid and High intensity interval training and essential amino acid supplement in people with Cardiovascular Risk Factor and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Risk Factor, Obesity
What is being tested?
High Intensity Interval Training, Essential Amino Acid and High intensity interval training and essential amino acid supplement
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteUnited States
Study dates
1 Mar 2019to 5 Jan 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Applied Physiology Laboratory, Fetzer Hall Room 25

    Chapel Hill, North Carolina, 27599

Other trials in United States

About this study

Official title: 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.

Being tested
High Intensity Interval Training, Essential Amino Acid, High intensity interval training and essential amino acid supplement
Medical subject headings
Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High Intensity Interval TrainingOther

    Exercise

  • Essential Amino AcidDietary supplement

    Oral ingestion of a powdered dietary supplement

  • High intensity interval training and essential amino acid supplementOther

    Exercise and dietary supplement

Study groups in NCT04080102
Study groupRoleWhat they receive
High intensity interval training (HIIT)ExperimentalNot described
Receives: Other: High Intensity Interval Training
Essential Amino Acid SupplementExperimentalNot described
Receives: Dietary Supplement: Essential Amino Acid
High intensity interval training + Essential Amino AcidExperimentalNot described
Receives: Other: High intensity interval training and essential amino acid supplement
ControlNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fat Free Mass (kg)

    Determined from a multi-compartment model

    Measured: 8 weeks

  2. Fat mass (kg)

    Determined from a multi-compartment model

    Measured: 8 weeks

Secondary outcomes (2)

  1. Muscle cross sectional area (cm3)

    Determined from ultrasound

    Measured: 8 weeks

  2. Echo intensity (a.u.)

    Determined from ultrasound

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start1 Mar 2019
  3. Primary completion5 Jan 2020
  4. Study completion5 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04080102
Sponsor's protocol ID
18-2726
Status last verified
Apr 2020
First submitted
26 Aug 2019
Last updated
30 Apr 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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).

Publications

  • Hirsch KR, Greenwalt CE, Cabre HE, Gould LM, Brewer GJ, Blue MNM, Ferrando AA, Huffman KM, Mayer-Davis EJ, Ryan ED, Smith-Ryan AE. Metabolic effects of high-intensity interval training and essential amino acids. Eur J Appl Physiol. 2021 Dec;121(12):3297-3311. doi: 10.1007/s00421-021-04792-4. Epub 2021 Aug 24.

    PubMed 34427732

Questions about this trial

What is this clinical trial studying?

A study testing High Intensity Interval Training, Essential Amino Acid and High intensity interval training and essential amino acid supplement in people with Cardiovascular Risk Factor and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fat Free Mass (kg) (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04080102, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2020.

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