120 Participants Needed

Reducose for Menopause

(CALM-R Trial)

What You Need to Know Before You Apply

What is the purpose of 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.

Are You a Good Fit for This Trial?

This trial is for women aged 40-60 who are experiencing menopausal symptoms and have a BMI of 18.5 to 35 kg/m2. They should be weight stable, not on hormone replacement therapy, and must have had a recent health check with normal diabetes markers. Participants need access to a smartphone to use specific apps.

Inclusion Criteria

I am a woman aged 40-60.
I am willing and able to follow the study's requirements.
I am a woman aged 40-60, my weight is stable, and my BMI is between 18.5 to 35.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks
1 visit (in-person)

Treatment

Participants receive daily Reducose® supplementation with the two largest meals for 12 weeks

12 weeks
Decentralized monitoring via CGM and app-based surveys

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • Reducose®

Trial Overview

The CALM-R study tests if Reducose® (mulberry leaf extract) can improve blood sugar control and ease menopause symptoms when taken with meals over 12 weeks. It's compared against a placebo in this double-blind study using continuous glucose monitoring and surveys.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Reducose® Mulberry Leaf ExtractExperimental Treatment1 Intervention
Group II: Matching PlaceboPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Phynova Group Ltd

Lead Sponsor

People Science

Collaborator