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
Qualifiers
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
Treatments tested in this trial
- Reducose® (Mulberry leaf extract)
- Placebo
Treatment groups
120 Participants
are divided into 2 treatment groupsSponsors and collaborators
Phynova Group Ltd
Lead sponsor
People Science
Collaborator
Source ClinicalTrials.gov