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

Study to Evaluate the Efficacy of Your Super's Moon Balance and Its Impact on Premenstrual Syndrome and Menstrual Symptoms

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.

Study Overview

• Status: Completed
• Conditions: Menstrual Pain; PMS; Menstrual Discomfort
• Intervention / Treatment: Dietary supplement: Moon Balance

Detailed Description

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
• Enrollment (Actual): 38
• 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: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dietary supplement; Dietary supplement: Moon Balance	Dietary supplement: Moon Balance; Moon Balance is a blend of 6 food ingredients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks
Changes in saliva cortisol levels	Change in saliva cortisol levels with an at-home test after 12 weeks compared to baseline results.	12 weeks

Collaborators and Investigators

• Sponsor: Your Super, INC.
• Collaborators: Citruslabs

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2022
• Primary Completion (Actual): May 31, 2022
• Study Completion (Actual): May 31, 2022

Study Registration Dates

• First Submitted: February 2, 2022
• First Submitted That Met QC Criteria: February 2, 2022
• First Posted (Actual): February 14, 2022

Study Record Updates

• Last Update Posted (Actual): June 21, 2022
• Last Update Submitted That Met QC Criteria: June 16, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Pain; Neurologic Manifestations; Menstruation Disturbances; Pelvic Pain; Dysmenorrhea; Premenstrual Syndrome
• Other Study ID Numbers: 20230MoonBalance

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

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