Daily Upgrade Trial

NCT07792603 | Not Yet Recruiting

• 1 other identifier: 26-1484
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Women

Keywords

Dietary Supplement; Exercise training; Amino Acid; Body composition

Outcome Measures

Primary Outcomes (2)

• Essential Amino Acid Kinetics

  Area under the curve for metabolomic responses

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

• Substrate Oxidation

  Respiratory exchange ratio (RER)

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

Secondary Outcomes (3)

• Lean Body Mass

  Baseline and week 4

• Muscle size

  Baseline week 4

• Fluid Kinetics

  Baseline, week 1, week 2, week 3, week 4

Other Outcomes (3)

• Muscle Oxygen Capacity

  Baseline and week 4

• Mood

  Baseline, week 4

• Skin

  Baseline, week 4

Study Arms (3)

Essential Amino Acids+

EXPERIMENTAL

Essential amino acids, creatine, magnesium, electrolytes consumed once (daily) with 8-12 oz of water.

Dietary Supplement: Essential Amino Acid+ plus HIIT

Placebo Comparator

PLACEBO COMPARATOR

Non-caloric placebo consumed once (daily) with 8-12 oz of water

Behavioral: Placebo plus HIIT

Whey Protein Isolate

ACTIVE COMPARATOR

1 serving whey protein isolate mixed with 8-12 oz of water

Dietary Supplement: No Exercise

Interventions

Essential Amino Acid+ plus HIIT DIETARY_SUPPLEMENT

Daily supplementation plus twice weekly supervised high intensity interval training for 3 weeks

Essential Amino Acids+

Placebo plus HIIT BEHAVIORAL

Daily supplementation with non-caloric placebo, plus twice weekly supervised high intensity interval training for 3 weeks.

Placebo Comparator

No Exercise DIETARY_SUPPLEMENT

No exercise, acute evaluation, whey protein intake only

Whey Protein Isolate

Eligibility Criteria

• Age: 25 Years - 45 Years
• Gender Eligibility Details: Biological females only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Sportiv, Inc.: collaborator

Study Sites (1)

Applied Physiology Laboratory

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Interventions

Amino Acids, Essential

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Abbie Smith-Ryan, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abbie Smith-Ryan, PhD

CONTACT

919-962-2574; abbiesmith@unc.edu

Research Coordinator

CONTACT

919-962-1663; aplresearch@unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)