Back to resultsAn Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance
Primary Purpose
Hormone Disturbance
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Semaine Hormonal Imbalance & The Daily
Sponsored by
About this trial
This is an interventional other trial for Hormone Disturbance
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.
Sites / Locations
- Citruslabs
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Intervention arm
Control arm
Arm Description
Semaine - The Daily
No intervention for the time period
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Changes in biomarkers linked to insulin sensitivity
Changes in Hemoglobin A1C between baseline and intervention period.
Changes in biomarkers linked to metabolic regulation
Changes in HOMA-IR values between baseline and intervention period.
Full Information
NCT ID
NCT05328609
First Posted
March 30, 2022
Last Updated
October 24, 2022
Sponsor
Semaine Health
Collaborators
Citruslabs
1. Study Identification
Unique Protocol Identification Number
NCT05328609
Brief Title
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
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
March 15, 2022 (Actual)
Primary Completion Date
June 15, 2022 (Actual)
Study Completion Date
June 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Semaine Health
Collaborators
Citruslabs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Disturbance
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Active Comparator
Arm Description
Semaine - The Daily
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
No intervention for the time period
Intervention Type
Dietary Supplement
Intervention Name(s)
Semaine Hormonal Imbalance & The Daily
Intervention Description
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.
Primary Outcome Measure Information:
Title
Discomfort associated with hormone imbalance
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Changes in biomarkers linked to insulin sensitivity
Description
Changes in Hemoglobin A1C between baseline and intervention period.
Time Frame
60 days
Title
Changes in biomarkers linked to metabolic regulation
Description
Changes in HOMA-IR values between baseline and intervention period.
Time Frame
60 days
Other Pre-specified Outcome Measures:
Title
Changes in perceived skin quality
Description
Changes in perceived skin quality using skin images of participants' faces to compare changes between baseline and intervention.
Time Frame
60 days
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States
12. IPD Sharing Statement
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An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Hormonal Imbalance
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