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

Not Applicable

Completed

• Conditions: Hormone Disturbance
• Interventions: Dietary Supplement: Semaine Hormonal Imbalance & The Daily

• Registration Number: NCT05328609
• Lead Sponsor: Semaine Health

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.

Detailed Description

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.

It is hypothesized that the dietary supplement marketed as The Daily will improve subjective wellbeing in trial participants. It is further hypothesized that the dietary supplement will improve plasma biomarkers that have been previously correlated with insulin resistance.

A total of 45 participants will be recruited for the trial following screening, with the expectation that at least 35 will complete the trial. The trial will be fully remote, and 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.

Study Timeline

• Study Start: 2022-03-15
• Study First Submitted: 2022-03-30
• Study First Submitted QC: 2022-04-06
• Study First Posted: 2022-04-14
• Primary Completion: 2022-06-15
• Study Completion: 2022-06-15
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-24
• Last Update Posted: 2022-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

Inclusion Criteria

• 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:

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention arm	Semaine Hormonal Imbalance & The Daily	Semaine - The Daily

Primary Outcome Measures

Name	Time	Method
Discomfort associated with hormone imbalance	60 days	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.

Secondary Outcome Measures

Name	Time	Method
Changes in biomarkers linked to metabolic regulation	60 days	Changes in HOMA-IR values between baseline and intervention period.
Changes in biomarkers linked to insulin sensitivity	60 days	Changes in Hemoglobin A1C between baseline and intervention period.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States