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A Nutritional Supplement on Vasomotor Symptoms in Women

NCT04516304 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2024-04-04

No results posted yet for this study

Summary

Vasomotor symptoms (VMS), such as flushes, sweating, and sleep disturbances, are experienced by up to 80% of women during the menopausal transition. Night sweats, which are hot flushes that occur at night, can be particularly bothersome in women and contribute to disturbed sleep. These symptoms occur mainly during the 1-3 years prior to menopause (late perimenopause) and early menopause (\~4 years after menstruation ceases). Many women look to supplements for the management of menopausal symptoms. Soy isoflavones and their metabolites are one category of dietary supplements that have been extensively studied for the management of VMS. The most active soy isoflavone is S-equol, which is not found directly in soy, but rather is the metabolite that is produced by gut microflora from consumption of the soy isoflavone daidzein. However, only 20-30% of US women are actually able to produce S-equol from the consumption of daidzein. Equelle® is a currently available dietary supplement that has S-equol as its active component, which allows the delivery of the active soy isoflavone metabolite directly without dependence on the gut microflora metabolism. The intention of this study is to assess the effect of a product containing S-equol on the management of VMS in normally healthy women.

Condition or disease: Vasomotor Symptoms

Intervention/treatment:

Dietary Supplement: S-equol Dietary Supplement: Placebo

Conditions

Interventions

DIETARY_SUPPLEMENT

Placebo

4 tablets/d (2 in the morning and 2 in the evening)

DIETARY_SUPPLEMENT

S-equol

4 tablets/d (2 in the morning and 2 in the evening), providing 10 mg S-equol total a day Other Names: •Equelle®

Sponsors & Collaborators

  • Biofortis, Merieux NutriSciences

    collaborator INDUSTRY

  • Pharmavite LLC

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-27
Primary Completion
2020-05-22
Completion
2020-05-22

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04516304 on ClinicalTrials.gov