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

NCT05617287 | Completed

• 1 other identifier: 20265
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Menopause; Menopause Related Conditions; Perimenopausal Disorder

Keywords

Menopause; Perimenopause

Outcome Measures

Primary Outcomes (1)

• Changes in perceived discomfort associated with the most common symptoms linked with perimenopause and menopause

  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

Study Arms (1)

Semaine Supplement

EXPERIMENTAL

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

Interventions

Semaine Menopause Supplement DIETARY_SUPPLEMENT

Synergistic Dietary Supplement

Semaine Supplement

Eligibility Criteria

• Age: 40 Years - 57 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 )

Sponsors & Collaborators

• Semaine Health: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

Study Officials

• Christopher Hill

  Citruslabs

  PRINCIPAL INVESTIGATOR

• Matthew Crane

  Semaine Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2022
• First Posted: November 15, 2022
• Study Start: September 3, 2022
• Primary Completion: January 1, 2023
• Study Completion: January 1, 2023
• Last Updated: April 13, 2023

Record last verified: 2023-04

Locations

US (1)