Clinical trial NCT05328609: An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance
Official title: An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hormone Disturbance
Lead sponsor: Semaine Health
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2022-04-14
Enrollment: 45
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Discomfort associated with hormone imbalance
timeFrame: 60 days
Secondary outcomes:
measure: Changes in biomarkers linked to insulin sensitivity
timeFrame: 60 days
measure: Changes in biomarkers linked to metabolic regulation
timeFrame: 60 days
Other outcomes:
measure: Changes in perceived skin quality
timeFrame: 60 days
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: