Healthy Women
Conditions
Keywords
Dietary Supplement, Exercise training, Amino Acid, Body composition
Brief summary
This study evaluates the acute and chronic effects of an essential amino acid supplement (Daily Upgrade EAA+) on metabolomics, amino acid kinetics, metabolic rate, body composition in active adult women. The study consists of an acute randomized double-blind crossover phase comparing EAA+, whey protein isolate, and placebo before high-intensity interval training (HIIT), and a chronic randomized double-blind parallel-arm phase evaluating 3 weeks of EAA+ or placebo supplementation combined with twice-weekly HIIT.
Detailed description
The trial includes an acute crossover phase and a chronic parallel-group phase. In the acute phase, participants complete three randomized laboratory visits during which they consume Daily Upgrade EAA+, whey protein isolate, or a non-caloric placebo prior to a standardized high-intensity interval training (HIIT) session. Metabolomic responses, amino acid kinetics, metabolic outcomes are assessed before and after exercise. In the chronic phase, participants are randomized to consume Daily Upgrade EAA+ or placebo daily for three weeks while completing supervised HIIT sessions twice per week. Outcomes assessed before and after the intervention include body composition, exercise performance, fluid balance, and gastrointestinal symptoms.
Interventions
DIETARY_SUPPLEMENTEssential Amino Acid+
Daily supplementation of essential amino acids
DIETARY_SUPPLEMENTNon-Calorie Placebo
Daily supplementation with non-caloric placebo
BEHAVIORALHigh intensity Interval Training
Twice weekly high intensity interval training for 3 weeks
OTHERNo Exercise
No exercise
Sponsors
University of North Carolina, Chapel Hill
Sportiv, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Intervention model description
This study incorporates two randomized intervention components within a single protocol. The primary trial is a double-blind, parallel-group study in which participants are randomized to receive either Daily Upgrade EAA+ or placebo during a 3-week supervised high-intensity interval training (HIIT) intervention. Embedded within the overall trial is an acute, randomized, double-blind crossover substudy in which a subset of participants completes three experimental visits and receives Daily Upgrade EAA+, whey protein isolate, and placebo in randomized order to evaluate acute metabolomic, metabolic, and physiological responses before and after HIIT.
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant is an adult between the ages of 25-45 years * Participant has a recorded BMI between 18.5-30 kg/m\^2 * Participant is apparently healthy and free from disease, as determined by a health history questionnaire * Participant is a biological female * Participant is naturally menstruating or uses a form of hormonal contraceptive * Participant is recreationally active, based on the International Physical Activity Questionnaire- Short Form * Participant agrees to abstain from caffeine (12 hours), tobacco, alcohol, and exercise for 24 hours prior to testing days * Participant is willing and able to comply with the protocol
Exclusion criteria
* Participant has been diagnosed with chronic heart disease, arrhythmias, thyroid disease, renal, hepatic, autoimmune or neurological diseases, as determined by a health history questionnaire. * Participant has a musculoskeletal disorder or injury that would prohibit them from being able to safely complete the study protocol. * Participant is currently enrolled in a separate clinical trial or weight loss program involving diet, exercise, physical activity, or the potential ingestion of an active drug or dietary supplement * Participant is using, or has consistently used one of the following dietary supplements within 1 month prior to enrollment: whey protein, creatine, essential amino acids * Participant has a known allergy or sensitivity to the placebo or active ingredients * Participant is pregnant or planning to become pregnant * Participant does not speak English or is hearing impaired
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Essential Amino Acid Kinetics | Baseline, 30, 60, and 90 minutes following supplementation during acute visits. | Area under the curve for metabolomic responses |
| Substrate Oxidation | Before (0 min) and after (30, 60, 90 min) one session of high intensity interval training | Respiratory exchange ratio (RER) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lean Body Mass | Baseline and week 4 | Dual energy x-ray absorptiometry-derived lean soft tissue |
| Muscle size | Baseline week 4 | Muscle cross sectional area derived from peripheral quantitative computed tomography |
| Fluid Kinetics | Baseline, week 1, week 2, week 3, week 4 | Total body water |
Countries
United States
Contacts
CONTACTAbbie Smith-Ryan, PhD
CONTACTResearch Coordinator
PRINCIPAL_INVESTIGATORAbbie Smith-Ryan, PhD
University of North Carolina, Chapel Hill
Outcome results
None listed