Healthy Women
Conditions
Keywords
perimenopause, protein supplement
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.
Interventions
DIETARY_SUPPLEMENTTriple protein support
Plant based protein + creatine + fiber
DIETARY_SUPPLEMENTPlacebo
Non-caloric matched placebo
Sponsors
University of North Carolina, Chapel Hill
Perelel Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Randomized, double-blind, placebo controlled parallel design
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postprandial glucose area under the curve (AUC) | Glucose measured over 0-120 minutes starting post standardized meal | Glucose measured at 0-120 minutes post-meal; AUC by trapezoidal method. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in insulin sensitivity (HOMA-IR) | Baseline, Week 6 | Calculated from fasting glucose and insulin. |
| Change in lean soft tissue | Baseline, week 6 | Lean soft tissue measured from whole body dual energy x-ray absorptiometry |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAbbie Smith-Ryan
University of North Carolina
Outcome results
None listed