Health TrialsbyHealthPanel

Daily Upgrade Trial

ConditionHealthy Women
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorUniversity of North Carolina, Chapel Hill

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant is an adult between the ages of 25-45 years

Participant has a recorded BMI between 18.5-30 kg/m²

Participant is apparently healthy and free from disease, as determined by a health history questionnaire

Participant is a biological female

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Essential Amino Acid+

    Dietary supplement

    Daily supplementation of essential amino acids

  • Non-Calorie Placebo

    Dietary supplement

    Daily supplementation with non-caloric placebo

  • High intensity Interval Training

    Behavioral

    Twice weekly high intensity interval training for 3 weeks

  • No Exercise

    Other intervention

    No exercise

Treatment groups

44 Participants
are divided into 3 treatment groups
Group A: Essential Amino Acids+Experimental treatment 2 interventions
Group B: Placebo ComparatorPlacebo comparator 2 interventions
Group C: Whey Protein IsolateActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Essential Amino Acid Kinetics

Area under the curve for metabolomic responses

Time frame
Baseline, 30, 60, and 90 minutes following supplementation during acute visits.
2

Substrate Oxidation

Respiratory exchange ratio (RER)

Time frame
Before (0 min) and after (30, 60, 90 min) one session of high intensity interval training

Secondary outcomes

1

Lean Body Mass

Dual energy x-ray absorptiometry-derived lean soft tissue

Time frame
Baseline and week 4
2

Muscle size

Muscle cross sectional area derived from peripheral quantitative computed tomography

Time frame
Baseline week 4
3

Fluid Kinetics

Total body water

Time frame
Baseline, week 1, week 2, week 3, week 4

Other outcomes

1

Muscle Oxygen Capacity

Near infrared spectroscopy

Time frame
Baseline and week 4
2

Mood

Questionnaire derived mood and fatigue from patient-reported outcomes measurement information system (PROMIS), score range 30-60, with higher scores representing worse mood.

Time frame
Baseline, week 4
3

Skin

Skin texture measured from the patient reported outcome measure, scored from 0 (lowest satisfaction/worst outcome) to 100 (highest satisfaction/best outcome).

Time frame
Baseline, week 4

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of North Carolina, Chapel Hill

Lead sponsor

Sportiv, Inc.

Collaborator

Source ClinicalTrials.gov
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