An interventional study of High Intensity Interval Training and Essential Amino Acid in Cardiovascular Risk Factor and Obesity, sponsored by University of North Carolina, Chapel Hill. Completed at 1 site in United States. Open to participants aged 30 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-30.
Sponsored by University of North Carolina, Chapel Hill · Not applicable, Interventional, and Prevention
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's enrollment of 84 is close to the median of 77 across 5,084 interventional studies indexed under Obesity.
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Exclusion Criteria:
Other: High Intensity Interval Training
Dietary Supplement: Essential Amino Acid
Other: High intensity interval training and essential amino acid supplement
Exercise
Oral ingestion of a powdered dietary supplement
Exercise and dietary supplement
Fat Free Mass (kg)
Determined from a multi-compartment model
Time frame: 8 weeks
Fat mass (kg)
Determined from a multi-compartment model
Time frame: 8 weeks
Muscle cross sectional area (cm3)
Determined from ultrasound
Time frame: 8 weeks
Echo intensity (a.u.)
Determined from ultrasound
Time frame: 8 weeks
Metabolic rate (kcal/day)
resting metabolic rate from indirect calorimetry
Time frame: 8 weeks
Plan to share: 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).
Time frame: Deidentified individual data that supports the results will be shared beginning 12 to 24 months following publication.
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.
This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Essential amino acid
University of North Carolina, Chapel Hill →