Impact of Reducose® on Glycemic Response and Menopausal Symptoms in Perimenopausal Women (CALM-R)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-60
SponsorPhynova Group Ltd
About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
Participants assigned male at birth.
Aged > 60 or < 40 years.
Pregnant or lactating.
Body mass index (BMI) > 35kg/m2 or < 18.5kg/m2
Trial design
Design model
Parallel
Treatments tested in this trial
Reducose® (Mulberry leaf extract)
Dietary supplementReducose® proprietary mulberry leaf extract, 250mg, 2/day with meals
Placebo
Dietary supplementPlacebo matching capsules, Microcrystalline Cellulose
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Reducose® Mulberry Leaf ExtractExperimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline and end-of-study test meals (Days 10, 14, and 98).Secondary outcomes
1
Time to peak glucose (Tmax) following test meal
Time from start of test meal to maximum postprandial glucose level measured by CGM.
Time frame
Days 10, 14, and 98.2
Peak glucose concentration (Cmax) following test meal
Maximum postprandial glucose level (mg/dL) measured by CGM.
Time frame
Days 10, 14, and 98.3
Fasting blood glucose prior to test meals
Fasting glucose level (mg/dL) obtained from CGM prior to test meals.
Time frame
Days 14 and 98.4
Mean Amplitude of Glycemic Excursions (MAGE)
CGM-derived glycemic variability metric calculated over predefined baseline and follow-up windows.
Time frame
Baseline (Days 7-14), Week 1 (Days 14-21), Week 11 (Days 85-92), Week 12 (Days 92-98).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Phynova Group Ltd
Lead sponsor
People Science
Collaborator
Source ClinicalTrials.gov