Hormone Disturbance
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSemaine 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.
Sponsors
Citruslabs
Semaine Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Changes in biomarkers linked to insulin sensitivity | 60 days | Changes in Hemoglobin A1C between baseline and intervention period. |
| Changes in biomarkers linked to metabolic regulation | 60 days | Changes in HOMA-IR values between baseline and intervention period. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in perceived skin quality | 60 days | Changes in perceived skin quality using skin images of participants' faces to compare changes between baseline and intervention. |
Countries
United States
Outcome results
None listed