Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome

Your Super, INC.38 enrolled

Overview

This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms, as well as health-related biomarkers.

It is hypothesized that the dietary supplement marketed as "YOUR SUPER Moon Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as pain, cramps, bloating, and lack of energy. Further, the ability of the supplement to reduce biomarkers of inflammation (CRP) and stress (cortisol), and promote sleep, will be evaluated.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

PMS Menstrual Discomfort Menstrual Pain

Interventions

Moon BalanceDIETARY_SUPPLEMENT

Moon Balance is a blend of 6 food ingredients

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Individuals with a regular menstruation * Age 18-40 * Moderate self-reported discomfort during menstruation-related to bloating, cramps, fatigue, mood swings, or other PMS-related symptoms * Must be in generally good health - no unstable, uncontrolled health condition * BMI under 35 * Self-reported sleep-issues * Willingness to refrain from ibuprofen or naproxen sodium (such as Advil, Aleve, Motrin or Midol) during each period (pill bleed) during the study * Agree to not change their diet significantly during the duration of the study * Agree to not change the intensity of their workouts for the duration of the study * Must get their period regularly Exclusion Criteria: * Severe chronic conditions, including oncological and psychiatric disorders * Known to have any severe allergic reactions * Currently pregnant, breastfeeding, or wanting to become pregnant for the duration of the study * Participants unwilling to follow the study protocol * Have used a similar product (ingredients) in the 6 weeks prior to the study

Locations (1)

Citruslabs

Santa Monica, California, United States

Outcomes

Primary Outcomes

Change in perceived discomfort associated with menstruation

Perceived discomfort caused by several of the most common menstrual symptoms (energy, sleep, mood, comfort, and overall fewer PMS symptoms) 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).

Time frame: 12 weeks

Secondary Outcomes

Change in blood biomarkers: C-reactive protein

Change in C-Reactive Protein (CRP) with an at-home blood test after 12 weeks compared to baseline results.

Time frame: 12 weeks

Changes in saliva cortisol levels

Change in saliva cortisol levels with an at-home test after 12 weeks compared to baseline results.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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