Impact of Reducose® on Glycemic Response and Menopausal Symptoms in Perimenopausal Women (CALM-R) (CALM-R)

The Impact of Reducose® on Symptoms of Perimenopause and Glycemic Response: a Randomized Controlled Trial

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 Overview

• Status: Recruiting
• Conditions: Glycemic Response; Menopause Symptoms
• Intervention / Treatment: Dietary supplement: Reducose® (Mulberry leaf extract); Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90034
      • Recruiting
      • People Science
      • Contact: Project Manager; Phone Number: 562-673-6744; Email: megha@peoplescience.health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Matching Placebo	Dietary supplement: Placebo; Placebo matching capsules, Microcrystalline Cellulose
Experimental: Reducose® Mulberry Leaf Extract	Dietary supplement: Reducose® (Mulberry leaf extract); Reducose® proprietary mulberry leaf extract, 250mg, 2/day with meals

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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	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)

Collaborators and Investigators

• Sponsor: Phynova Group Ltd
• Collaborators: People Science

Study record dates

Study Major Dates

• Study Start (Actual): December 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 5, 2026
• First Posted (Estimated): January 12, 2026

Study Record Updates

• Last Update Posted (Estimated): January 12, 2026
• Last Update Submitted That Met QC Criteria: January 5, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Menopause
• Other Study ID Numbers: PYN-PS18-14914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No