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NCT Number: NCT07526571

GLOW Study: Effects of Triple Protein 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.

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Key information

Conditions

Healthy Women

Age range

30 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Exercise and Sport Science, Applied Physiology Laboratory

Chapel Hill, North Carolina, 27713, United States

Location status: Recruiting

Location contact

Applied Physiology Laboratory

CONTACT

[email protected]

919-962-1663

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triple protein support

Dietary Supplement

Plant based protein + creatine + fiber

Placebo

Dietary Supplement

Non-caloric matched placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in insulin sensitivity (HOMA-IR)

    Time frame: Baseline, Week 6

    Calculated from fasting glucose and insulin.

  2. Change in lean soft tissue

    Time frame: Baseline, week 6

    Lean soft tissue measured from whole body dual energy x-ray absorptiometry

Study contacts

Contact information is provided by the study sponsor or research team.

Abbie Smith-Ryan

CONTACT

[email protected]

919-962-1663

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • Perelel Inc.

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 13, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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