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NCT Number: NCT07792603

Daily Upgrade 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.

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Key information

Conditions

Age range

25 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Abbie Smith-Ryan, PhD

PRINCIPAL_INVESTIGATOR

Research Coordinator

CONTACT

[email protected]

919-962-1663

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

No exercise

Primary outcomes

  1. Essential Amino Acid Kinetics

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

    Area under the curve for metabolomic responses

  2. Substrate Oxidation

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

    Respiratory exchange ratio (RER)

Secondary outcomes

  1. Lean Body Mass

    Time frame: Baseline and week 4

    Dual energy x-ray absorptiometry-derived lean soft tissue

  2. Muscle size

    Time frame: Baseline week 4

    Muscle cross sectional area derived from peripheral quantitative computed tomography

  3. Fluid Kinetics

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

    Total body water

Other outcomes

  1. Muscle Oxygen Capacity

    Time frame: Baseline and week 4

    Near infrared spectroscopy

  2. Mood

    Time frame: Baseline, week 4

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

  3. Skin

    Time frame: Baseline, week 4

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

Study contacts

Contact information is provided by the study sponsor or research team.

Abbie Smith-Ryan, PhD

CONTACT

[email protected]

919-962-2574

Research Coordinator

CONTACT

[email protected]

919-962-1663

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Sportiv, Inc.

Registry information

Official study title

TONE UP: Daily Upgrade Trial: Tone, Oxygenation, Neuromood, Energy - Upgrade Evaluation

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 28, 2026
Registry last updated
Sep 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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