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

Semaine Health

Status

Completed

Conditions

Hormone Disturbance

Treatments

Dietary Supplement: Semaine Hormonal Imbalance & The Daily

Study type

Interventional

Funder types

Industry

Identifiers

NCT05328609

20228Semaine

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

Female

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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.