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

Hormone Disturbance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05328609
• Other study ID #: 20228Semaine
• Status: Completed
• Phase: N/A
• Start date: March 15, 2022
• Est. completion date: June 15, 2022

Study information

• Verified date: October 2022
• Source: Semaine Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Endocrine System Diseases
• Hormone Disturbance

Intervention

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.

Locations

Country	Name	City	State
United States	Citruslabs	Santa Monica	California

Sponsors (2)

Lead Sponsor	Collaborator
Semaine Health	Citruslabs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in perceived skin quality	Changes in perceived skin quality using skin images of participants' faces to compare changes between baseline and intervention.	60 days
Primary	Discomfort associated with hormone imbalance	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.	60 days
Secondary	Changes in biomarkers linked to insulin sensitivity	Changes in Hemoglobin A1C between baseline and intervention period.	60 days
Secondary	Changes in biomarkers linked to metabolic regulation	Changes in HOMA-IR values between baseline and intervention period.	60 days