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

September 4, 2026 updated by: Phynova Group Ltd

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90034
        • People Science

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Glycemic response following test meal
Time Frame: 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.
Baseline and end-of-study test meals (Days 3,7,91).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to peak glucose (Tmax) following test meal
Time Frame: Days 3, 7 and 91.
Time from start of test meal to maximum postprandial glucose level measured by CGM.
Days 3, 7 and 91.
Peak glucose concentration (Cmax) following test meal
Time Frame: Days 3, 7, and 91.
Maximum postprandial glucose level (mg/dL) measured by CGM.
Days 3, 7, and 91.
Fasting blood glucose prior to test meals
Time Frame: Days 7 and 91.
Fasting glucose level (mg/dL) obtained from CGM prior to test meals.
Days 7 and 91.
Mean Amplitude of Glycemic Excursions (MAGE)
Time Frame: Days 0-16 and 80-95
CGM-derived glycemic variability metric calculated over predefined baseline and follow-up windows.
Days 0-16 and 80-95
Nighttime Gross Coefficient of Variation (%CV)
Time Frame: Days 0-16 and 80-95
CGM-derived nighttime glucose variability from 23:00-06:00.
Days 0-16 and 80-95
Menopausal symptoms (Greene Climacteric Scale total score)
Time Frame: Days 7, 35, 63, 91
Change in Greene Climacteric Scale (0-60) assessing vasomotor, somatic, psychological symptoms. Direction of Improvement: Lower score indicates improvement.
Days 7, 35, 63, 91
Sleep disturbance (PROMIS Sleep Disturbance Short Form-6a)
Time Frame: Day 5 and 91
Participant-reported sleep disturbance via validated PROMIS Sleep Disturbance-SF6a. Direction of Improvement: Higher score indicates improvement.
Day 5 and 91
Quality of Life questionnaire
Time Frame: Day 5 and 91
App-based questionnaires assessing perceived quality of life changes. Direction of Improvement: Higher score indicates improvement.
Day 5 and 91
Product Experience Questionnaire
Time Frame: 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,.
Day 91

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Phynova Group Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
People Science, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 12, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 11, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 5, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 9, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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