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

Study Overview
=================
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.

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

Conditions
-----------------
Hormone Disturbance

Intervention / Treatment
-----------------
* Dietary Supplement: Semaine Hormonal Imbalance & The Daily


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention arm<br>Semaine - The Daily | Dietary Supplement: Semaine Hormonal Imbalance & The Daily<br>* 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.<br>|
| No Intervention: Control arm<br>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 |