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

NCT07333885 | Recruiting

• 1 other identifier: PYN-PS18-14914
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause Symptoms; Glycemic Response

Keywords

Menopause

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Time to peak glucose (Tmax) following test meal

  Days 10, 14, and 98.

• Peak glucose concentration (Cmax) following test meal

  Days 10, 14, and 98.

• Fasting blood glucose prior to test meals

  Days 14 and 98.

• Mean Amplitude of Glycemic Excursions (MAGE)

  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)

  Baseline (Days 7-14), Week 1 (Days 14-21), Week 11 (Days 85-92), Week 12 (Days 92-98).

Study Arms (2)

Reducose® Mulberry Leaf Extract

EXPERIMENTAL

Dietary Supplement: Reducose® (Mulberry leaf extract)

Matching Placebo

PLACEBO COMPARATOR

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo matching capsules, Microcrystalline Cellulose

Matching Placebo

Reducose® (Mulberry leaf extract) DIETARY_SUPPLEMENT

Reducose® proprietary mulberry leaf extract, 250mg, 2/day with meals

Reducose® Mulberry Leaf Extract

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Phynova Group Ltd: lead
• People Science: collaborator

Study Sites (1)

People Science

Los Angeles, California, 90034, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment (two-arm RCT)

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 12, 2026
• Study Start: December 12, 2025
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: January 12, 2026

Record last verified: 2026-01

Locations

US (1)