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

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.

Study Overview

• Status: Completed
• Conditions: Hormone Disturbance
• Intervention / Treatment: Dietary supplement: Semaine Hormonal Imbalance & The Daily

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 Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention arm; Semaine - The Daily	Dietary supplement: Semaine Hormonal Imbalance & The Daily; 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.
No Intervention: Control arm; No intervention for the time period

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in perceived skin quality	Changes in perceived skin quality using skin images of participants' faces to compare changes between baseline and intervention.	60 days

Collaborators and Investigators

• Sponsor: Semaine Health
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Actual): June 15, 2022
• Study Completion (Actual): June 15, 2022

Study Registration Dates

• First Submitted: March 30, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 14, 2022

Study Record Updates

• Last Update Posted (Actual): October 26, 2022
• Last Update Submitted That Met QC Criteria: October 24, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases
• Other Study ID Numbers: 20228Semaine

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No