Status:
COMPLETED
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance
Lead Sponsor:
Semaine Health
Collaborating Sponsors:
Citruslabs
Conditions:
Hormone Disturbance
Eligibility:
FEMALE
18-55 years
Phase:
NA
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 d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 15 2022
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05328609
Start Date
March 15 2022
End Date
June 15 2022
Last Update
October 26 2022
Active Locations (1)
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1
Citruslabs
Santa Monica, California, United States, 90404