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

• Sponsor: Your Super, INC. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT05237661
• Collaborator: Citruslabs (Industry)
• Enrollment: 38
• Location: 1
• Arm: 1
• Actual Duration (Months): 3.4
• Patients Per Site Per Month: 11

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
PMS; Menstrual Discomfort; Menstrual Pain	Dietary Supplement: Moon Balance	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 38 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Study to Evaluate the Efficacy of Your Super's Moon Balance and Its Impact on Premenstrual Syndrome and Menstrual Symptoms
• Actual Study Start Date: Feb 15, 2022
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: May 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in perceived discomfort associated with menstruation [12 weeks]

   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).

Secondary Outcome Measures

1. Change in blood biomarkers: C-reactive protein [12 weeks]

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

2. Changes in saliva cortisol levels [12 weeks]

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

Eligibility Criteria

Criteria

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Citruslabs	Santa Monica	California	United States	90404

Sponsors and Collaborators

• Your Super, INC.
• Citruslabs

Investigators

• Principal Investigator: Susanne Mitschke, Citruslabs

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Your Super, INC.
• ClinicalTrials.gov Identifier: NCT05237661
• Other Study ID Numbers: 20230MoonBalance
• First Posted: Feb 14, 2022
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Premenstrual Syndrome; Dysmenorrhea

Study Results

No Results Posted as of Jun 21, 2022