An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms
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|ClinicalTrials.gov Identifier: NCT05019924|
Recruitment Status : Completed
First Posted : August 25, 2021
Last Update Posted : March 24, 2022
|Condition or disease||Intervention/treatment||Phase|
|Menstrual Pain Menstrual Discomfort||Dietary Supplement: Semaine||Not Applicable|
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 Semaine PMS & Period Support will improve subjective wellbeing and biomarkers in trial participants.
A total of 58 participants will be recruited for the trial following screening, with the expectation that at least 51 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. For both menstrual cycles the participants will complete a subjective wellbeing survey and provide a blood sample for biomarker analysis.
The biomarker analysis will be performed through an at-home fingerprick blood test. To maximize consistency, the tests should be performed on the same days of each cycle - preferably on days 4 or 5. If absolutely necessary, however one day of buffer on either side will be allowed.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms|
|Actual Study Start Date :||August 1, 2021|
|Actual Primary Completion Date :||November 30, 2021|
|Actual Study Completion Date :||November 30, 2021|
Active Comparator: Intervention arm
Dietary Supplement: Semaine
The dietary supplement is designed, and marketed commercially to be taken in servings of two capsules per day, up to four times per day (a total of 8 capsules daily). Most consumers, however, will only take a serving three times per day, or one with each major meal (breakfast, lunch and dinner).
No Intervention: Control arm
No intervention given
- Change in perceived discomfort associated with menstruation [Time Frame: Baseline to 8 weeks) [ Time Frame: 8 week intervention period ]
Perceived discomfort caused by several of the most common menstrual symptoms Cramping Bloating Gastrointestinal issues (diarrhea or constipation) Feeling tired Feeling down emotionally Feeling anxious Headache
Each endpoint will be reported by the participant on a scale of perceived discomfort at the end of each menstrual cycle. Participants will complete the surveys for each menstrual cycle. The study uses a questionnaire including a scale from 0-7 to assess the severity of symptoms(0=no symptoms and 7=very severe symptoms).
To ensure consistency between participants, each survey will be completed on days 7 or 8 after they stop hormonal contraception usage (or begin placebo pills).
- Change in blood biomarkers: C-Reactive Protein (CRP) and 25-hydroxyvitamin D [Time Frame: Baseline to 8 weeks] [ Time Frame: 8 week intervention period ]Change in C-Reactive Protein (CRP) and 25-hydroxyvitamin D biomarkers measured with an at-home blood test after 8 weeks compared to baseline results.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05019924
|United States, California|
|Santa Monica, California, United States, 90404|