Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Citruslabs | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention arm | Active Comparator | Semaine - The Daily |
|
| Control arm | No Intervention | No intervention for the time period |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Semaine Hormonal Imbalance & The Daily | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in biomarkers linked to insulin sensitivity | Changes in Hemoglobin A1C between baseline and intervention period. | 60 days |
| Changes in biomarkers linked to metabolic regulation | Changes in HOMA-IR values between baseline and intervention period. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
Female
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Citruslabs | Santa Monica | California | 90404 | United States |
Not provided
| ID | Term |
|---|---|
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 60 days |