Impact of Reducose® on Glycemic Response and Menopausal Symptoms in Perimenopausal Women (CALM-R)

Official title

The Impact of Reducose® on Symptoms of Perimenopause and Glycemic Response: a Randomized Controlled Trial

Overview

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.

Interventions

• Dietary supplement Reducose® (Mulberry leaf extract)
  Reducose® proprietary mulberry leaf extract, 250mg, 2/day with meals
• Dietary supplement Placebo
  Placebo matching capsules, Microcrystalline Cellulose

Primary outcome measures

• Glycemic response following test meal [Time frame: Baseline and end-of-study test meals (Days 10, 14, and 98).]

Secondary outcome measures (9)

• Time to peak glucose (Tmax) following test meal [Time frame: Days 10, 14, and 98.]
• Peak glucose concentration (Cmax) following test meal [Time frame: Days 10, 14, and 98.]
• Fasting blood glucose prior to test meals [Time frame: Days 14 and 98.]
• Mean Amplitude of Glycemic Excursions (MAGE) [Time frame: Baseline (Days 7-14), Week 1 (Days 14-21), Week 11 (Days 85-92), Week 12 (Days 92-98).]
• Nighttime Gross Coefficient of Variation (%CV) [Time frame: Baseline (Days 7-14), Week 1 (Days 14-21), Week 11 (Days 85-92), Week 12 (Days 92-98).]
• Menopausal symptoms (Greene Climacteric Scale total score) [Time frame: Screening/Day 0, Days 14, 42, 70, 98.]
• Sleep disturbance (PROMIS Sleep Disturbance Short Form-6a) [Time frame: Baseline (Day 5) and end of study (Day 98).]
• Quality of Life questionnaire [Time frame: Baseline (Day 5) and end of study (Day 98).]
• Product Experience Questionnaire [Time frame: End of study (Day 98)]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 1 center

• People Science — Los Angeles

Identifiers

NCT: NCT07333885 · PYN-PS18-14914

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗