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| Name | Class |
|---|---|
| People Science | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reducose® Mulberry Leaf Extract | Experimental |
| |
| Matching Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reducose® (Mulberry leaf extract) | Dietary Supplement | Reducose® proprietary mulberry leaf extract, 250mg, 2/day with meals |
|
| Measure | Description | Time Frame |
|---|---|---|
| Glycemic 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. | Baseline and end-of-study test meals (Days 10, 14, and 98). |
| Measure | Description | Time Frame |
|---|---|---|
| Time to peak glucose (Tmax) following test meal | Time from start of test meal to maximum postprandial glucose level measured by CGM. | Days 10, 14, and 98. |
| Peak glucose concentration (Cmax) following test meal |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| People Science | Recruiting | Los Angeles | California | 90034 | United States |
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Parallel Assignment (two-arm RCT)
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This study is a randomized, double-blind, placebo-controlled trial. Participants, care providers, investigators, and outcomes assessors are blinded to intervention assignment. Study products are labeled as Product A or Product B, and the randomization code is maintained by the sponsor and only broken in the event of a serious adverse event.
| Placebo | Dietary Supplement | Placebo matching capsules, Microcrystalline Cellulose |
|
Maximum postprandial glucose level (mg/dL) measured by CGM.
| Days 10, 14, and 98. |
| Fasting blood glucose prior to test meals | Fasting glucose level (mg/dL) obtained from CGM prior to test meals. | Days 14 and 98. |
| Mean Amplitude of Glycemic Excursions (MAGE) | CGM-derived glycemic variability metric calculated over predefined baseline and follow-up windows. | 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. | 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. | 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. | 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. | 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,. | End of study (Day 98) |