GLOW Study: Effects of Triple Protein in Women

NCT07526571 | Recruiting

• 1 other identifier: 25-2541
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Women

Keywords

perimenopause; protein supplement

Outcome Measures

Primary Outcomes (1)

• Change in postprandial glucose area under the curve (AUC)

  Glucose measured at 0-120 minutes post-meal; AUC by trapezoidal method.

  Glucose measured over 0-120 minutes starting post standardized meal

Secondary Outcomes (2)

• Change in insulin sensitivity (HOMA-IR)

  Baseline, Week 6

• Change in lean soft tissue

  Baseline, week 6

Study Arms (2)

Triple Protein Support

EXPERIMENTAL

Daily one serving of plant-based protein + creatine + fiber mixed with 8-12 fl oz water for 4 weeks

Dietary Supplement: Triple protein support

Placebo

PLACEBO COMPARATOR

Daily one serving of a non-caloric, texture- and weight-matched placebo for 4 weeks

Dietary Supplement: Placebo

Interventions

Triple protein support DIETARY_SUPPLEMENT

Plant based protein + creatine + fiber

Triple Protein Support

Placebo DIETARY_SUPPLEMENT

Non-caloric matched placebo

Placebo

Eligibility Criteria

• Age: 30 Years - 60 Years
• Gender Eligibility Details: Biologic females only
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Currently supplementing whey protein.
• Pregnant or nursing.
• Lactose intolerant.
• Currently using creatine monohydrate.
• Severe hearing or speech impairment or inability to speak English

Sponsors & Collaborators

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

Study Sites (1)

Department of Exercise and Sport Science, Applied Physiology Laboratory

Chapel Hill, North Carolina, 27713, United States

RECRUITING

Study Officials

• Abbie Smith-Ryan

  University of North Carolina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abbie Smith-Ryan

CONTACT

919-962-1663; aplresearch@unc.edu

Study Design

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

Model Details: Randomized, double-blind, placebo controlled parallel design

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning after primary results publication and for up to 2 years thereafter
• Access Criteria: Access will be granted to qualified researchers who submit a methodologically sound proposal for noncommercial research purposes, contingent upon: Consistency with the IRB-approved informed consent, Compliance with HIPAA and applicable regulations, Execution of an appropriate Data Use Agreement (DUA), Approval by the Study Sponsor and/or the Institution, as required

Locations

US (1)