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

What this trial studies

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 in scope

• Glycemic Response
• Menopause Symptoms

Interventions

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

Who can join

Women only · Ages 40 Years to 60 Years · Accepts healthy volunteers.

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.

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.

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-12-12
• Primary completion: 2026-06
• Last update posted: 2026-01-12
• First posted: 2026-01-12

Sponsor & contact

Lead sponsor: Phynova Group Ltd (Industry)

Collaborators: People Science

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Glycemic response following test meal (Baseline and end-of-study test meals (Days 10, 14, and 98).)
  Postprandial glycemic response measured as 0-120-minute incremental area under the curve (iAUC) from interstitial glucose readings captured by Dexcom Stelo CGM.

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.