GLOW Study: Effects of Triple Protein in Women

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.

Study Overview

• Status: Recruiting
• Conditions: Healthy Women
• Intervention / Treatment: Dietary supplement: Triple protein support; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Abbie Smith-Ryan; Phone Number: 919-962-1663; Email: aplresearch@unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27713
      • Recruiting
      • Department of Exercise and Sport Science, Applied Physiology Laboratory
      • Contact: Applied Physiology Laboratory; Phone Number: 919-962-1663; Email: aplresearch@unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Triple Protein Support; Daily one serving of plant-based protein + creatine + fiber mixed with 8-12 fl oz water for 4 weeks	Dietary supplement: Triple protein support; Plant based protein + creatine + fiber
Placebo Comparator: Placebo; Daily one serving of a non-caloric, texture- and weight-matched placebo for 4 weeks	Dietary supplement: Placebo; Non-caloric matched placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in insulin sensitivity (HOMA-IR)	Calculated from fasting glucose and insulin.	Baseline, Week 6
Change in lean soft tissue	Lean soft tissue measured from whole body dual energy x-ray absorptiometry	Baseline, week 6

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Perelel Inc.
• Investigators: Principal Investigator: Abbie Smith-Ryan, University of North Carolina

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 6, 2026
• First Submitted That Met QC Criteria: April 6, 2026
• First Posted (Actual): April 13, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: perimenopause; protein supplement
• Other Study ID Numbers: 25-2541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified IPD may be shared in accordance with the informed consent, IRB approval, sponsor agreement, and institutional policies.
• IPD Sharing Time Frame: Beginning after primary results publication and for up to 2 years thereafter
• IPD Sharing 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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No