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.
• 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.