Actively Recruiting
Impact of Reducose® on Glycemic Response and Menopausal Symptoms in Perimenopausal Women (CALM-R)
Led by Phynova Group Ltd · Updated on 2026-01-12
120
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
Sponsors
P
Phynova Group Ltd
Lead Sponsor
P
People Science
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Impact of Reducose® on Glycemic Response and Menopausal Symptoms in Perimenopausal Women (CALM-R)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants assigned female at birth aged 40 to 60 years
- Weight stable females with BMI between 18.5 to 35 kg/m2
- Willing to maintain current diet and physical activity during the study
- Had a medical physical screening with healthy diabetes blood markers within the last 12 months
- Self-reported age over 40 years with irregular periods
- Willing and able to follow the study protocol
- Provided voluntary informed consent
- Not currently using hormone replacement therapy or stopped more than 3 months ago
- Experiencing menopause symptoms with a minimum score of 12/60 on the Greene Climacteric Scale
- Own or have constant access to a smartphone and able to download Dexcom and Chloe apps
- Willing to use reliable non-hormonal contraception during the study
- In good general health at screening
- Able to read, understand, and provide informed consent in English
- Able to receive shipments within the United States
- Able to complete study assessments over up to 12 weeks
You will not qualify if you...
- Participants assigned male at birth
- Age below 40 or above 60 years
- Pregnant or lactating
- BMI greater than 35 kg/m2 or less than 18.5 kg/m2
- Fasting blood glucose above 126 mg/dL or HbA1c above 6.5% in the last 12 months
- Known history of diabetes or use of diabetes medications or insulin
- Currently using hormone replacement therapy or used it within the last 3 months
- Postmenopausal with amenorrhea over 12 months
- Medically induced or surgical menopause
- History of hysterectomy or full/partial removal of ovaries
- Known allergy or intolerance to mulberry extract or related foods
- Medical conditions or medications affecting glucose, appetite, digestion, or absorption including thyroid conditions, inflammatory bowel disease, incretin mimetics
- Previous bariatric surgery
- Use of steroids, protease inhibitors, antipsychotics, antidepressants affecting glucose or body fat
- Significant or untreated medical or psychiatric disorders including heart disease, renal failure, liver disease, AIDS, cancer, epilepsy, recent stroke or brain injury
- Excessive alcohol intake or drug abuse in past 6 months
- Current tobacco or cannabis use including vaping
- Extremely restrictive diet currently or in past 3 months
- Significant weight change (±5 lbs) in past 3 months
- Cognitive impairment or unable to provide informed consent
- Use of medications or supplements significantly affecting blood glucose
- Major medical, surgical, psychiatric event requiring hospitalization in past 3 months
- Use of certain over-the-counter herbal or hormonal supplements
- Participation in another clinical trial within 30 days prior to randomization
- Lack of smartphone or internet access or unwilling to use study apps
- Unlikely to comply with study protocol or considered unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
People Science
Los Angeles, California, United States, 90034
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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