Glycemic ResponseCALM-RNCT07333885
Impact of Reducose® on Glycemic Response and Menopausal Symptoms in Perimenopausal Women (CALM-R)
A study testing Reducose® (Mulberry leaf extract) in people with Glycemic Response and Menopause Symptoms, run by Phynova Group Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Glycemic Response, Menopause Symptoms
- What is being tested?
- Reducose® (Mulberry leaf extract)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to 11 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Glycemic Response, Menopause Symptoms
- Being tested
- Reducose® (Mulberry leaf extract), Placebo
- Keywords
- Menopause
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducose® (Mulberry leaf extract)Dietary supplement
Reducose® proprietary mulberry leaf extract, 250mg, 2/day with meals
PlaceboDietary supplement
Placebo matching capsules, Microcrystalline Cellulose
| Study group | Role | What they receive |
|---|---|---|
| Reducose® Mulberry Leaf Extract | Experimental | Not described Receives: Dietary Supplement: Reducose® (Mulberry leaf extract) |
| Matching Placebo | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and end-of-study test meals (Days 3,7,91).
Secondary outcomes (9)
Time to peak glucose (Tmax) following test meal
Time from start of test meal to maximum postprandial glucose level measured by CGM.
Measured: Days 3, 7 and 91.
Peak glucose concentration (Cmax) following test meal
Maximum postprandial glucose level (mg/dL) measured by CGM.
Measured: Days 3, 7, and 91.
Fasting blood glucose prior to test meals
Fasting glucose level (mg/dL) obtained from CGM prior to test meals.
Measured: Days 7 and 91.
Mean Amplitude of Glycemic Excursions (MAGE)
CGM-derived glycemic variability metric calculated over predefined baseline and follow-up windows.
Measured: Days 0-16 and 80-95
Nighttime Gross Coefficient of Variation (%CV)
CGM-derived nighttime glucose variability from 23:00-06:00.
Measured: Days 0-16 and 80-95
Menopausal symptoms (Greene Climacteric Scale total score)
Change in Greene Climacteric Scale (0-60) assessing vasomotor, somatic, psychological symptoms. Direction of Improvement: Lower score indicates improvement.
Measured: Days 7, 35, 63, 91
Sleep disturbance (PROMIS Sleep Disturbance Short Form-6a)
Participant-reported sleep disturbance via validated PROMIS Sleep Disturbance-SF6a. Direction of Improvement: Higher score indicates improvement.
Measured: Day 5 and 91
Quality of Life questionnaire
App-based questionnaires assessing perceived quality of life changes. Direction of Improvement: Higher score indicates improvement.
Measured: Day 5 and 91
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,.
Measured: Day 91
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start12 Dec 2025
- Primary completion1 Aug 2026
- Study completion11 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glycemic ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Assignment (two-arm RCT)
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Phynova Group Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07333885
- Sponsor's protocol ID
- PYN-PS18-14914
- Acronym
- CALM-R
- Status last verified
- Sep 2026
- First submitted
- 19 Dec 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Reducose® on Symptoms of Perimenopause and Glycemic Response: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07333885
- Acronym / sponsor ID
- CALM-R / PYN-PS18-14914
- Conditions
- Glycemic Response, Menopause Symptoms
- Keywords
- Menopause
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Phynova Group LtdIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 1 Aug 2026 (actual)
- Study completion
- 11 Aug 2026 (actual)
- First posted
- 12 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Assignment (two-arm RCT)
| Arm | Type | Receives |
|---|---|---|
| Reducose® Mulberry Leaf Extract | Experimental | Dietary Supplement: Reducose® (Mulberry leaf extract) |
| Matching Placebo | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (26 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reducose® (Mulberry leaf extract)Reducose® proprietary mulberry leaf extract, 250mg, 2/day with meals | Dietary supplement | Reducose® Mulberry Leaf Extract |
| PlaceboPlacebo matching capsules, Microcrystalline Cellulose | Dietary supplement | Matching Placebo |
Primary outcome
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.
9 secondary outcomes
Time to peak glucose (Tmax) following test meal
Time frame: Days 3, 7 and 91.
Peak glucose concentration (Cmax) following test meal
Time frame: Days 3, 7, and 91.
Fasting blood glucose prior to test meals
Time frame: Days 7 and 91.
Mean Amplitude of Glycemic Excursions (MAGE)
Time frame: Days 0-16 and 80-95
Nighttime Gross Coefficient of Variation (%CV)
Time frame: Days 0-16 and 80-95
Menopausal symptoms (Greene Climacteric Scale total score)
Time frame: Days 7, 35, 63, 91
Sleep disturbance (PROMIS Sleep Disturbance Short Form-6a)
Time frame: Day 5 and 91
Quality of Life questionnaire
Time frame: Day 5 and 91
Product Experience Questionnaire
Time frame: Day 91
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducose® (Mulberry leaf extract) in people with Glycemic Response and Menopause Symptoms, run by Phynova Group Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic response following test meal (time frame: Baseline and end-of-study test meals (Days 3,7,91).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.