Glycemic Response, Menopause Symptoms
Conditions
Keywords
Menopause
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTReducose® (Mulberry leaf extract)
Reducose® proprietary mulberry leaf extract, 250mg, 2/day with meals
DIETARY_SUPPLEMENTPlacebo
Placebo matching capsules, Microcrystalline Cellulose
Sponsors
Phynova Group Ltd
People Science, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Parallel Assignment (two-arm RCT)
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Participants assigned female at birth (aged 40-60 years) will be recruited for the study. * Females ages 40-60 who are weight stable and with a self- reported Body Mass Index (BMI) between 18.5 to 35 kg/m2. * Willing to maintain their existing dietary and physical activity patterns throughout the study period. * Have received a medical physical screening (annual physical) within the last 12 months where blood markers for diabetes were taken and results were within the healthy range. * Self-reported \>40yrs in age and experiencing irregular periods. * Willing and able to comply with the study protocol. * Has given voluntary informed consent to participate in the study. * Not currently using hormone replacement therapy (HRT) and/or \>3months since their last hormone treatment. * Experiencing menopause symptoms and meets the minimum score of 12/60 on the Greene Climacteric Scale (GCS). * Own or have constant access to a smart phone and the apple or android app stores and are willing and able to download the Dexcom and Chloe apps and accept their respective privacy policies. * Willing to practice a reliable method of non-hormonal contraception for the duration of the study. * In good general health at the time of screening (Investigator discretion). * Able to read, understand, and provide informed consent in English. * Able to receive shipment of the product at an address within the United States. * Able to complete study assessments over the course of up to 12 weeks.
Exclusion criteria
* Participants assigned male at birth. * Aged \> 60 or \< 40 years. * Pregnant or lactating. * Body mass index (BMI) \> 35kg/m2 or \< 18.5kg/m2 * Fasting blood glucose \>126mg/dL and/or HbA1c \>6.5% reported in routine medical physical screening within the last 12-months. * Known history of diabetes mellitus (Type I/II) or the use of antihyperglycemic drugs or insulin to treat diabetes and related conditions. * Currently using hormone replacement therapy (HRT) or had hormone therapy in the last 3 months. * Postmenopausal, experiencing amenorrhea for \>12months. * Underwent medically induced or surgical menopause. * History of hysterectomy or full or partial oophorectomy. * Any known food allergy or intolerance including mulberry extract. * Medical condition(s) or medication(s) known to affect glucose regulation or appetite and/or influence digestion and absorption of nutrients, including thyroid conditions, active inflammatory bowel disease (Crohn's disease or ulcerative colitis) and incretin mimetics (GLP-1, Semaglutide, Dulagluetide, Tirzepatide, etc.) * Previously undergone bariatric surgery. * Use steroids, protease inhibitors, antipsychotics, antidepressants (including selective serotonin reuptake inhibitors and monoamine oxidase inhibitors) (all of which have effects on glucose metabolism and body fat distribution). * Significant or untreated medical and/or psychiatric disorders including but not limited myocardial ischemia or infarction, unstable angina, uncontrolled hypertension, renal failure and serious renal diseases, undergoing dialysis, chronic active hepatitis, acute hepatitis, cirrhosis of liver, AIDS, malignancy or neurological disorders including epilepsy, recent cerebrovascular disease or recent traumatic brain injury. * Alcohol intake above recommendations (\>2 standard alcoholic drinks per day) or drug abuse or dependence within the past 6 months. * Currently smoke tobacco and cannabis products (including vaping). * Consuming extremely restrictive diet currently or within past 3 months. * Weight has varied significantly (+/- 5 lbs) in the past 3 months. * Cognitively impaired and/or who are unable to give informed consent. * Taking daily medications or dietary supplements that have a significant effect on blood glucose control either as a primary function or side effect. * Subject to a major medical, surgical or major depressive or psychiatric event requiring hospitalization within the preceding 3 months. * Use of over the counter medications like Herbal Supplements: Black Cohosh, Dong Quai, Maca Root, Red Clover, Chaste Tree Berry (Vitex), Soy Isoflavones, Ashwagandha; OTC Non-Herbal Supplements: DHEA, Progesterone Cream (Bioidentical), Melatonin. * Participation in any other clinical research trial within 30 days prior to randomization. * Do not have a personal smartphone, internet access, or unwilling to download Chloe or use a Dexcom Continuous Glucose Monitoring Device. * Are unlikely for any reason to be able to comply with the study protocol, do not provide informed consent, or considered unsuited for participation in the study by the Principal Investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic response following test meal | Baseline and end-of-study test meals (Days 3,7,91). | Postprandial glycemic response measured as 0-120-minute incremental area under the curve (iAUC) from interstitial glucose readings captured by Dexcom Stelo CGM. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to peak glucose (Tmax) following test meal | Days 3, 7 and 91. | Time from start of test meal to maximum postprandial glucose level measured by CGM. |
| Peak glucose concentration (Cmax) following test meal | Days 3, 7, and 91. | Maximum postprandial glucose level (mg/dL) measured by CGM. |
| Fasting blood glucose prior to test meals | Days 7 and 91. | Fasting glucose level (mg/dL) obtained from CGM prior to test meals. |
| Mean Amplitude of Glycemic Excursions (MAGE) | Days 0-16 and 80-95 | CGM-derived glycemic variability metric calculated over predefined baseline and follow-up windows. |
| Nighttime Gross Coefficient of Variation (%CV) | Days 0-16 and 80-95 | CGM-derived nighttime glucose variability from 23:00-06:00. |
| Menopausal symptoms (Greene Climacteric Scale total score) | Days 7, 35, 63, 91 | Change in Greene Climacteric Scale (0-60) assessing vasomotor, somatic, psychological symptoms. Direction of Improvement: Lower score indicates improvement. |
| Sleep disturbance (PROMIS Sleep Disturbance Short Form-6a) | Day 5 and 91 | Participant-reported sleep disturbance via validated PROMIS Sleep Disturbance-SF6a. Direction of Improvement: Higher score indicates improvement. |
| Product Experience Questionnaire | Day 91 | Questionnaire for experience while taking product and use of Chloe App. Higher score indicates higher satisfaction with product and use of Chloe App,. |
| Quality of Life questionnaire | Day 5 and 91 | App-based questionnaires assessing perceived quality of life changes. Direction of Improvement: Higher score indicates improvement. |
Countries
United States
Outcome results
None listed