Healthy WomenNCT07792603
Daily Upgrade Trial
A study testing Essential Amino Acid+, High intensity Interval Training and No Exercise in people with Healthy Women, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Essential Amino Acid+, High intensity Interval Training and No Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Applied Physiology Laboratory
Chapel Hill, North Carolina, 27599
Research Coordinator, 919-962-1663, aplresearch@unc.edu
Abbie Smith-Ryan, PhD
About this study
Official title: TONE UP: Daily Upgrade Trial: Tone, Oxygenation, Neuromood, Energy - Upgrade Evaluation
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.
Read the 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.
- Conditions
- Healthy Women
- Being tested
- Essential Amino Acid+, Non-Calorie Placebo, High intensity Interval Training, No Exercise
- Keywords
- Dietary Supplement, Exercise training, Amino Acid, Body composition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Essential Amino Acid+Dietary supplement
Daily supplementation of essential amino acids
Non-Calorie PlaceboDietary supplement
Daily supplementation with non-caloric placebo
High intensity Interval TrainingBehavioural
Twice weekly high intensity interval training for 3 weeks
No ExerciseOther
No exercise
| Study group | Role | What they receive |
|---|---|---|
| Essential Amino Acids+ | Experimental | Essential amino acids, creatine, magnesium, electrolytes consumed once (daily) with 8-12 oz of water. Receives: Dietary Supplement: Essential Amino Acid+; Behavioral: High intensity Interval Training |
| Placebo Comparator | Placebo comparator | Non-caloric placebo consumed once (daily) with 8-12 oz of water Receives: Dietary Supplement: Non-Calorie Placebo; Behavioral: High intensity Interval Training |
| Whey Protein Isolate | Active comparator | 1 serving whey protein isolate mixed with 8-12 oz of water Receives: Other: No Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Essential Amino Acid Kinetics
Area under the curve for metabolomic responses
Measured: Baseline, 30, 60, and 90 minutes following supplementation during acute visits.
Substrate Oxidation
Respiratory exchange ratio (RER)
Measured: Before (0 min) and after (30, 60, 90 min) one session of high intensity interval training
Secondary outcomes (3)
Lean Body Mass
Dual energy x-ray absorptiometry-derived lean soft tissue
Measured: Baseline and week 4
Muscle size
Muscle cross sectional area derived from peripheral quantitative computed tomography
Measured: Baseline week 4
Fluid Kinetics
Total body water
Measured: Baseline, week 1, week 2, week 3, week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start31 Aug 2026
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy WomenStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Sportiv, Inc.
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07792603
- Sponsor's protocol ID
- 26-1484
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 3 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TONE UP: Daily Upgrade Trial: Tone, Oxygenation, Neuromood, Energy - Upgrade Evaluation
- ClinicalTrials.gov ID
- NCT07792603
- Acronym / sponsor ID
- 26-1484
- Conditions
- Healthy Women
- Keywords
- Dietary Supplement, Exercise training, Amino Acid, Body composition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Sportiv, Inc.
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Essential Amino Acids+ | Experimental | Dietary Supplement: Essential Amino Acid+, Behavioral: High intensity Interval TrainingEssential amino acids, creatine, magnesium, electrolytes consumed once (daily) with 8-12 oz of water. |
| Placebo Comparator | Placebo comparator | Dietary Supplement: Non-Calorie Placebo, Behavioral: High intensity Interval TrainingNon-caloric placebo consumed once (daily) with 8-12 oz of water |
| Whey Protein Isolate | Active comparator | Other: No Exercise1 serving whey protein isolate mixed with 8-12 oz of water |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Essential Amino Acid+Daily supplementation of essential amino acids | Dietary supplement | Essential Amino Acids+ |
| Non-Calorie PlaceboDaily supplementation with non-caloric placebo | Dietary supplement | Placebo Comparator |
| High intensity Interval TrainingTwice weekly high intensity interval training for 3 weeks | Behavioural | Essential Amino Acids+, Placebo Comparator |
| No ExerciseNo exercise | Other | Whey Protein Isolate |
Primary outcome
Essential Amino Acid Kinetics
Time frame: Baseline, 30, 60, and 90 minutes following supplementation during acute visits.
Area under the curve for metabolomic responses
Substrate Oxidation
Time frame: Before (0 min) and after (30, 60, 90 min) one session of high intensity interval training
Respiratory exchange ratio (RER)
3 secondary outcomes
Lean Body Mass
Time frame: Baseline and week 4
Muscle size
Time frame: Baseline week 4
Fluid Kinetics
Time frame: Baseline, week 1, week 2, week 3, week 4
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Abbie Smith-Ryan, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Essential Amino Acid+, High intensity Interval Training and No Exercise in people with Healthy Women, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abbie Smith-Ryan, PhD (919-962-2574, abbiesmith@unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Essential Amino Acid Kinetics (time frame: Baseline, 30, 60, and 90 minutes following supplementation during acute visits.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.