An Exploratory Investigation of Dietary Supplementation and the Effect on Common PMS and Menstrual Symptoms

• ClinicalTrials.gov Identifier: NCT05019924
• Recruitment Status: Completed
• First Posted: August 25, 2021
• Last Update Posted: March 24, 2022
• Sponsor: Semaine Health
• Collaborator: Citruslabs
• Information provided by (Responsible Party): Semaine Health

Study Description

Brief Summary:

Dietary supplementation is widely used to alleviate various symptoms of PMS and menstruation such as bloating and cramping. Providing a combination of synergistic dietary supplements is hypothesized to significantly reduce self-reported PMS and menstrual discomfort when compared with a baseline without the intervention.

Condition or disease	Intervention/treatment	Phase
Menstrual Pain; Menstrual Discomfort	Dietary Supplement: Semaine	Not Applicable

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 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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 58 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Intervention arm; Dietary supplement	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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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 18-40
• Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study
• Ability to take oral medication and be willing to adhere to the dietary supplement regimen
• Use of hormonal contraception for at least 3 months prior to screening and agreement to use such a method during study participation. Hormonal contraception must allow for pill bleeds to occur.
• Moderate self-reported discomfort during menstruation related to bloating, pelvic cramps, fatigue or mood swings. On a scale of 1-10, participants must report at least a 4 on two or more symptoms.
• Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration

Exclusion Criteria:

• Current use of GnRH agonists and antagonists including Lupron or Orilissa
• Current use of an extended activity hormonal contraception (for example, Depo-provera or Nexplanon)
• Current use of hyperthyroid medication such as methimazole
• Current use of blood thinning medication
• Pregnancy, lactation, or attempting to become pregnant during study
• Known allergic reactions to components of the dietary supplement (sunflower oil, ashwagandha, curcumin, resveratrol, Boswellia, milk thistle, quercetin or catechins)

Contacts and Locations

Locations

United States, California

Citruslabs

Santa Monica, California, United States, 90404

Sponsors and Collaborators

Semaine Health

Citruslabs

More Information

• Responsible Party: Semaine Health
• ClinicalTrials.gov Identifier: NCT05019924
• Other Study ID Numbers: 20216
• First Posted: August 25, 2021
• Last Update Posted: March 24, 2022
• Last Verified: March 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided
• Plan Description: This study will be conducted in accordance with the following publication and data sharing policies: the study will be published in an open-access preprint server, and every attempt will be made to publish the results in an open-access peer-reviewed journal. The study administrators (CitrusLabs) will be acknowledged in the publications. This trial will be registered with clinicaltrials.gov and results will be submitted to clinicaltrials.gov following publication.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Semaine Health:

PMS; Menstrual symptoms

Additional relevant MeSH terms:

Dysmenorrhea; Menstruation Disturbances; Pathologic Processes; Pelvic Pain; Pain; Neurologic Manifestations