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Recruiting NCT07526571

GLOW Study: Effects of Triple Protein in Women

No phase Interventional Healthy Women

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Triple protein support, Placebo.
Who it may be relevant to
Registry conditions: Healthy Women. Basic parameters: 30 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

GLOW Study: A Randomized Trial to Evaluate the Effects of Triple Support Protein on Glucose, Lifestyle, and Overall Well-being in Women

Overview

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.

Interventions

  • Dietary supplement Triple protein support
    Plant based protein + creatine + fiber
  • Dietary supplement Placebo
    Non-caloric matched placebo

Primary outcome measures

  • Change in postprandial glucose area under the curve (AUC) [Time frame: Glucose measured over 0-120 minutes starting post standardized meal]
Secondary outcome measures (2)
  • Change in insulin sensitivity (HOMA-IR) [Time frame: Baseline, Week 6]
  • Change in lean soft tissue [Time frame: Baseline, week 6]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Department of Exercise and Sport Science, Applied Physiology Laboratory — Chapel Hill

Identifiers

NCT: NCT07526571 · 25-2541

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗