GLOW Study: Effects of Triple Protein in Women | NCT07526571

Studies
GLOW Study: Effects of Triple Protein in Women

NCT07526571

Sponsor

University of North Carolina, Chapel Hill

Status

Recruiting

Last Update Posted

Apr 13, 2026Actual

Enrollment

40Estimated

Phase

Not Applicable

Conditions

Healthy Women

Interventions

Triple protein support
Placebo

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

Dec 1, 2026Estimated

First Submitted Date

Apr 6, 2026

First Submission Date that Met QC Criteria

Apr 6, 2026

First Posted Date

Apr 13, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 6, 2026

Last Update Posted Date

Apr 13, 2026Actual

Name	Class
Perelel Inc.	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Triple protein support	Dietary Supplement	Plant based protein + creatine + fiber	Triple Protein Support

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Biologic females only

Minimum Age

30 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Abbie Smith-Ryan	Contact	919-962-1663		aplresearch@unc.edu

Overall Officials

Name	Affiliation	Role
Abbie Smith-Ryan	University of North Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Exercise and Sport Science, Applied Physiology Laboratory	Recruiting	Chapel Hill	North Carolina	27713	United States

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

De-identified IPD may be shared in accordance with the informed consent, IRB approval, sponsor agreement, and institutional policies.

Types

Study Protocol
Statistical Analysis Plan (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

URL

Not provided