An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance

NCT05328609 | Completed

• 1 other identifier: 20228Semaine
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label observational trial to study the effectiveness of a commercial dietary supplement and its effect on common symptoms of normal menstrual discomfort.

Conditions

Hormone Disturbance

Outcome Measures

Primary Outcomes (1)

• Discomfort associated with hormone imbalance

  Changes in discomfort associated with the most common symptoms linked with perceived hormone imbalance. This outcome measure utilizes a questionnaire using the Likert scale (1-5) with lower values representing an improvement.

  60 days

Secondary Outcomes (2)

• Changes in biomarkers linked to insulin sensitivity

  60 days

• Changes in biomarkers linked to metabolic regulation

  60 days

Other Outcomes (1)

• Changes in perceived skin quality

  60 days

Study Arms (2)

Intervention arm

ACTIVE COMPARATOR

Semaine - The Daily

Dietary Supplement: Semaine Hormonal Imbalance & The Daily

Control arm

NO INTERVENTION

No intervention for the time period

Interventions

Semaine Hormonal Imbalance & The Daily DIETARY_SUPPLEMENT

All participants will undergo a menstrual cycle without intervention to establish a baseline, and then will be given the intervention (dietary supplement) for a second menstrual cycle.

Intervention arm

Eligibility Criteria

• Age: 18 Years - 55 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Female, aged 18-55 (roughly 75% 18-38 and 25% 45-55)
• Ability to take oral medication and be willing to adhere to the dietary supplement regimen (2 capsules per day)
• Willing to fast overnight (12+ hours) prior to the blood collection, and to perform an at-home fingerprick blood test
• Moderate self-reported discomfort related to perceived hormone imbalance. Participants must answer B or C on at least 3 of the following questions:

You may not qualify if:

• Current use of medication for high blood pressure or for blood thinning
• Diabetic, or on medication such as Metformin or Acarbose
• Pregnancy, breastfeeding, or attempting to become pregnant during study
• Known allergic reactions to components of the dietary supplement (sunflower oil, passionflower, berberine, or grape seed extract )
• Has exercised 3+ times per week of 30 minutes or more per session on average over the past 6 month
• On a ketogenic or vegan diet for more than the past 30 days
• If hormonal birth control, cannot stop during the duration of the study.

Sponsors & Collaborators

• Semaine Health: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2022
• First Posted: April 14, 2022
• Study Start: March 15, 2022
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: October 26, 2022

Record last verified: 2022-10

Locations

US (1)