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

NCT ID: NCT05328609

Last Updated: 2022-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-15
• Study Completion Date: 2022-06-15

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.

Conditions

Hormone Disturbance

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention arm

Semaine - The Daily

Group Type: ACTIVE_COMPARATOR

Semaine Hormonal Imbalance & The Daily

Intervention Type: DIETARY_SUPPLEMENT

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.

Control arm

No intervention for the time period

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Semaine 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.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

Semaine Health

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Other Identifiers

20228Semaine

Identifier Type: -

Identifier Source: org_study_id