Healthy WomenNCT07526571
GLOW Study: Effects of Triple Protein in Women
A study testing Triple protein support in people with Healthy Women, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
This single-site, randomized, blinded, placebo-controlled study will evaluate whether 4 weeks of daily Triple Support Protein powder improves glycemic control and overall well-being in healthy women aged 30-60 years. Read more about this study
- Who is it for?
- Ages 30 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Women
- What is being tested?
- Triple protein support
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2026to 12 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 30 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Females aged 30-60 years.
- BMI 18.5-40 kg/m^2.
- Recreationally active (≥30 min/wk moderate intensity exercise).
- Healthy and free from disease per health history questionnaire.
- Willing to abstain from caffeine, tobacco, and alcohol for 24 hours before testing days.
Who cannot join
- Currently supplementing whey protein.
- Pregnant or nursing.
- Lactose intolerant.
- Currently using creatine monohydrate.
- Severe hearing or speech impairment or inability to speak English
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Exercise and Sport Science, Applied Physiology Laboratory
Chapel Hill, North Carolina, 27713
About this study
Official title: GLOW Study: A Randomized Trial to Evaluate the Effects of Triple Support Protein on Glucose, Lifestyle, and Overall Well-being in Women
This single-site, randomized, blinded, placebo-controlled study will evaluate whether 4 weeks of daily Triple Support Protein powder improves glycemic control and overall well-being in healthy women aged 30-60 years. Participants will undergo baseline testing (DXA, fasting blood, standardized meal test with 2-hour glucose and insulin sampling), complete one acute supervised dose, and then consume a daily supplement for 4 weeks. During the final 14 days, participants will wear a continuous glucose monitor. Outcomes include postprandial glucose AUC, insulin sensitivity, and body composition.
Read the detailed description
Midlife women experience hormonal changes that can impair metabolic health, sleep, and cognition. Triple plant-based protein powder includes creatine and fiber aimed at glycemic control, muscle support, and satiety. Design: 40 participants randomized (1:1) to Triple Protein Support vs. matched placebo for 4 weeks, with acute and chronic phases, weekly check-ins. Assessments: Baseline and end-of-study DXA and bloods; standardized meal tests with 2-hour glucose/insulin sampling; Analysis: Mixed-model ANOVA for primary and secondary endpoints with α=0.05.
- Conditions
- Healthy Women
- Being tested
- Triple protein support, Placebo
- Keywords
- perimenopause, protein supplement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Triple protein supportDietary supplement
Plant based protein + creatine + fiber
PlaceboDietary supplement
Non-caloric matched placebo
| Study group | Role | What they receive |
|---|---|---|
| Triple Protein Support | Experimental | Daily one serving of plant-based protein + creatine + fiber mixed with 8-12 fl oz water for 4 weeks Receives: Dietary Supplement: Triple protein support |
| Placebo | Placebo comparator | Daily one serving of a non-caloric, texture- and weight-matched placebo for 4 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in postprandial glucose area under the curve (AUC)
Glucose measured at 0-120 minutes post-meal; AUC by trapezoidal method.
Measured: Glucose measured over 0-120 minutes starting post standardized meal
Secondary outcomes (2)
Change in insulin sensitivity (HOMA-IR)
Calculated from fasting glucose and insulin.
Measured: Baseline, Week 6
Change in lean soft tissue
Lean soft tissue measured from whole body dual energy x-ray absorptiometry
Measured: Baseline, week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start10 Apr 2026
- Primary completion12 Aug 2026
- Study completion12 Aug 2026
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo controlled parallel design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Perelel Inc.
- Responsible party
- Sponsor
- Investigators
- Abbie Smith-Ryan, Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526571
- Sponsor's protocol ID
- 25-2541
- Status last verified
- Aug 2026
- First submitted
- 6 Apr 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD may be shared in accordance with the informed consent, IRB approval, sponsor agreement, and institutional policies.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GLOW Study: A Randomized Trial to Evaluate the Effects of Triple Support Protein on Glucose, Lifestyle, and Overall Well-being in Women
- ClinicalTrials.gov ID
- NCT07526571
- Acronym / sponsor ID
- 25-2541
- Conditions
- Healthy Women
- Keywords
- perimenopause, protein supplement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Perelel Inc.
- Study start
- 10 Apr 2026 (actual)
- Primary completion
- 12 Aug 2026 (actual)
- Study completion
- 12 Aug 2026 (actual)
- First posted
- 13 Apr 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 single-site, randomized, blinded, placebo-controlled study will evaluate whether 4 weeks of daily Triple Support Protein powder improves glycemic control and overall well-being in healthy women aged 30-60 years. Participants will undergo baseline testing (DXA, fasting blood, standardized meal test with 2-hour glucose and insulin sampling), complete one acute supervised dose, and then consume a daily supplement for 4 weeks. During the final 14 days, participants will wear a continuous glucose monitor. Outcomes include postprandial glucose AUC, insulin sensitivity, and body composition.
Detailed description
Midlife women experience hormonal changes that can impair metabolic health, sleep, and cognition. Triple plant-based protein powder includes creatine and fiber aimed at glycemic control, muscle support, and satiety. Design: 40 participants randomized (1:1) to Triple Protein Support vs. matched placebo for 4 weeks, with acute and chronic phases, weekly check-ins. Assessments: Baseline and end-of-study DXA and bloods; standardized meal tests with 2-hour glucose/insulin sampling; Analysis: Mixed-model ANOVA for primary and secondary endpoints with α=0.05.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo controlled parallel design
| Arm | Type | Receives |
|---|---|---|
| Triple Protein Support | Experimental | Dietary Supplement: Triple protein supportDaily one serving of plant-based protein + creatine + fiber mixed with 8-12 fl oz water for 4 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily one serving of a non-caloric, texture- and weight-matched placebo for 4 weeks |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Females aged 30-60 years.
- BMI 18.5-40 kg/m^2.
- Recreationally active (≥30 min/wk moderate intensity exercise).
- Healthy and free from disease per health history questionnaire.
- Willing to abstain from caffeine, tobacco, and alcohol for 24 hours before testing days.
Key exclusion criteria (5 listed)
- Currently supplementing whey protein.
- Pregnant or nursing.
- Lactose intolerant.
- Currently using creatine monohydrate.
- Severe hearing or speech impairment or inability to speak English
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 |
|---|---|---|
| Triple protein supportPlant based protein + creatine + fiber | Dietary supplement | Triple Protein Support |
| PlaceboNon-caloric matched placebo | Dietary supplement | Placebo |
Primary outcome
Change in postprandial glucose area under the curve (AUC)
Time frame: Glucose measured over 0-120 minutes starting post standardized meal
Glucose measured at 0-120 minutes post-meal; AUC by trapezoidal method.
2 secondary outcomes
Change in insulin sensitivity (HOMA-IR)
Time frame: Baseline, Week 6
Change in lean soft tissue
Time frame: Baseline, week 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Individual participant dataSharing planned: Yes. De-identified IPD may be shared in accordance with the informed consent, IRB approval, sponsor agreement, and institutional policies.
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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. This study is not recruiting at the moment.
Abbie Smith-Ryan principal investigator
University of North Carolina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Triple protein support 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 19 Aug 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in postprandial glucose area under the curve (AUC) (time frame: Glucose measured over 0-120 minutes starting post standardized meal). 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 19 Aug 2026.