An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause

April 11, 2023 updated by: Semaine Health
A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

42

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Monica, California, United States, 90404
        • Citruslabs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

36 years to 53 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day)
  • Moderate self-reported discomfort related to perimenopause or menopause. Participants will complete the menopause well-being survey and must answer an average of "moderate" or higher.

Exclusion Criteria:

  • Current use of medication for high blood pressure or for blood thinning
  • Currently undergoing chemotherapy or has previously been treated for cancer
  • Pregnancy, breastfeeding, or attempting to become pregnant during the study
  • Known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Semaine Supplement
Participants are provided with a dietary supplement and are instructed to take 1 capsule per day. Participants are to take the supplement at the same time every day. If forgotten, they are to take it with the next meal. Participants will take a well-being assessment after each month (4 surveys total including the baseline.)
Dietary supplement: Semaine Menopause Supplement
Synergistic Dietary Supplement

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause
Time Frame: 12 weeks

Symptoms will be reported by the participant on a scale of perceived discomfort and will include rankings for mood, anxiety, fatigue, sleep quality, hot flashes, and libido.

This survey will be based on the widely used and validated Menopause Rating Scale (MRS). The MRS will be modified to increase dynamic range by changing the response gradations from 5 to 7.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Semaine Health

Collaborators

Citruslabs

Investigators

  • Principal Investigator: Matthew Crane, Semaine Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 3, 2022

Primary Completion (Actual)

January 1, 2023

Study Completion (Actual)

January 1, 2023

Study Registration Dates

First Submitted

November 7, 2022

First Submitted That Met QC Criteria

November 7, 2022

First Posted (Actual)

November 15, 2022

Study Record Updates

Last Update Posted (Actual)

April 13, 2023

Last Update Submitted That Met QC Criteria

April 11, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20265

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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