120 Participants Needed

Reducose for Menopause

(CALM-R Trial)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if Reducose® (a mulberry leaf extract) can improve blood sugar levels and ease menopause symptoms in women. Participants will take the supplement with their two largest meals each day for 12 weeks. Continuous glucose monitors and surveys will track changes. Women aged 40-60, experiencing irregular periods and menopause symptoms, and who have not recently used hormone therapy, may be suitable candidates. As an unphased trial, this study offers an opportunity to contribute to research that could enhance menopause management.

Will I have to stop taking my current medications?

Yes, you may need to stop taking certain medications, especially those that affect blood sugar levels or include specific supplements like Black Cohosh or Melatonin. It's best to discuss your current medications with the study team to see if they are allowed.

Is there any evidence suggesting that Reducose® is likely to be safe for humans?

Research has shown that Reducose, an extract from mulberry leaves, is generally safe for people. It has been tested in nine clinical trials to evaluate its effectiveness in reducing blood sugar spikes after meals. These studies have not identified any major safety issues, indicating good tolerance among participants. Researchers are also exploring Reducose for its potential to help with menopause symptoms and improve blood sugar control. While specific side effects aren't listed, the absence of reported problems in earlier trials suggests a positive safety profile. As always, consulting a healthcare provider before joining a trial is important.12345

Why are researchers excited about this trial?

Reducose® is unique because it uses mulberry leaf extract, a natural ingredient, to help manage menopause symptoms. Unlike hormone replacement therapies, which are the standard treatment and come with various side effects, Reducose® offers a potential alternative with a natural approach. Researchers are excited about this treatment because it could provide a safer option with fewer side effects, leveraging the natural properties of the mulberry leaf to improve quality of life for those experiencing menopause.

What evidence suggests that Reducose® might be an effective treatment for menopause?

In earlier studies, Reducose®, an extract from mulberry leaves, has shown promise for improving health. Nine different human trials have proven it significantly lowers blood sugar spikes after meals and reduces insulin levels. This helps stabilize blood sugar, which is crucial for managing conditions like diabetes. Some early studies also suggest it might help with menopause symptoms, such as mood swings and sleep problems. While more research is needed to confirm these effects, current evidence supports its potential benefits for managing blood sugar and easing menopause symptoms. Participants in this trial will receive either Reducose® or a matching placebo to further evaluate its effects on menopause symptoms.12346

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

Citations

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