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

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Pain; Menstrual Discomfort
• Intervention / Treatment: Dietary supplement: Semaine

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 Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Santa Monica, California, United States, 90404
      • Citruslabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in perceived discomfort associated with menstruation [Time Frame: Baseline to 8 weeks)	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).	8 week intervention period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood biomarkers: C-Reactive Protein (CRP) and 25-hydroxyvitamin D [Time Frame: Baseline to 8 weeks]	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.	8 week intervention period

Collaborators and Investigators

• Sponsor: Semaine Health
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): November 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 19, 2021
• First Posted (Actual): August 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 22, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: PMS; Menstrual symptoms
• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea
• Other Study ID Numbers: 20216 (University of Kansas)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No