The purpose of this double-blind, randomized, placebo-controlled trial is to. evaluate daily Reducose® (mulberry leaf extract) supplementation taken with the two largest meals for 12 weeks on improving glycemic response and perimenopausal symptoms in women aged 40-60 years. Glycemic response is measured using Dexcom Stelo continuous glucose monitors during standardized test meals, and menopausal symptoms and sleep/quality-of-life outcomes are assessed using validated surveys administered through the Chloe app in a decentralized U.S. study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Reducose® proprietary mulberry leaf extract, 250mg, 2/day with meals
Placebo matching capsules, Microcrystalline Cellulose
People Science
Los Angeles, California, United States
RECRUITINGGlycemic response following test meal
Postprandial glycemic response measured as 0-120-minute incremental area under the curve (iAUC) from interstitial glucose readings captured by Dexcom Stelo CGM.
Time frame: Baseline and end-of-study test meals (Days 10, 14, and 98).
Time to peak glucose (Tmax) following test meal
Time from start of test meal to maximum postprandial glucose level measured by CGM.
Time frame: Days 10, 14, and 98.
Peak glucose concentration (Cmax) following test meal
Maximum postprandial glucose level (mg/dL) measured by CGM.
Time frame: Days 10, 14, and 98.
Fasting blood glucose prior to test meals
Fasting glucose level (mg/dL) obtained from CGM prior to test meals.
Time frame: Days 14 and 98.
Mean Amplitude of Glycemic Excursions (MAGE)
CGM-derived glycemic variability metric calculated over predefined baseline and follow-up windows.
Time frame: Baseline (Days 7-14), Week 1 (Days 14-21), Week 11 (Days 85-92), Week 12 (Days 92-98).
Nighttime Gross Coefficient of Variation (%CV)
CGM-derived nighttime glucose variability from 23:00-06:00.
Time frame: Baseline (Days 7-14), Week 1 (Days 14-21), Week 11 (Days 85-92), Week 12 (Days 92-98).
Menopausal symptoms (Greene Climacteric Scale total score)
Change in Greene Climacteric Scale (0-60) assessing vasomotor, somatic, psychological symptoms. The minimum possible score is 0 and the maximum possible score is 63 with a score of 21 indicating a woman is experiencing menopause-related symptom patterns. Direction of Improvement: Lower score indicates improvement.
Time frame: Screening/Day 0, Days 14, 42, 70, 98.
Sleep disturbance (PROMIS Sleep Disturbance Short Form-6a)
Participant-reported sleep disturbance via validated PROMIS Sleep Disturbance-SF6a. For scoring, the raw score range of 8 (lowest possible) to 40 (highest possible). A score of 50 is average for sleep disturbance. Direction of Improvement: Higher score indicates improvement.
Time frame: Baseline (Day 5) and end of study (Day 98).
Quality of Life questionnaire
App-based questionnaires assessing perceived quality of life changes. Direction of Improvement: Higher score indicates improvement.
Time frame: Baseline (Day 5) and end of study (Day 98).
Product Experience Questionnaire
Questionnaire for experience while taking product and use of Chloe App. Higher score indicates higher satisfaction with product and use of Chloe App,.
Time frame: End of study (Day 98)
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