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

Sponsor

Semaine Health (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05328609

Collaborator

Citruslabs (Industry)

Enrollment

Location

Arms

Anticipated Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hormone Disturbance	Dietary Supplement: Semaine Hormonal Imbalance & The Daily	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 15, 2022

Anticipated Primary Completion Date :

Jun 15, 2022

Anticipated Study Completion Date :

Jun 15, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Intervention arm Semaine - The Daily	Dietary Supplement: 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.
No Intervention: Control arm No intervention for the time period

Arm

Intervention/Treatment

Active Comparator: Intervention arm

Semaine - The Daily

Dietary Supplement: 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.

No Intervention: Control arm

No intervention for the time period

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

Semaine Health
Citruslabs

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Semaine Health

ClinicalTrials.gov Identifier:

NCT05328609

Other Study ID Numbers:

20228Semaine

First Posted:

Apr 14, 2022

Last Update Posted:

Apr 14, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Endocrine System Diseases

Study Results

No Results Posted as of Apr 14, 2022