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

Primary Purpose

PMS, Menstrual Discomfort, Menstrual Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Moon Balance
Sponsored by
Your Super, INC.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PMS

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Citruslabs

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Dietary supplement

Arm Description

Dietary supplement: Moon Balance

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

Full Information

First Posted
February 2, 2022
Last Updated
June 16, 2022
Sponsor
Your Super, INC.
Collaborators
Citruslabs
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1. Study Identification

Unique Protocol Identification Number
NCT05237661
Brief Title
Study to Evaluate Your Super's Moon Balance and Its Impact on Premenstrual Syndrome
Official Title
Study to Evaluate the Efficacy of Your Super's Moon Balance and Its Impact on Premenstrual Syndrome and Menstrual Symptoms
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 15, 2022 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
May 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Your Super, INC.
Collaborators
Citruslabs

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
PMS, Menstrual Discomfort, Menstrual Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dietary supplement
Arm Type
Experimental
Arm Description
Dietary supplement: Moon Balance
Intervention Type
Dietary Supplement
Intervention Name(s)
Moon Balance
Intervention Description
Moon Balance is a blend of 6 food ingredients
Primary Outcome Measure Information:
Title
Change in perceived discomfort associated with menstruation
Description
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 Outcome Measure Information:
Title
Change in blood biomarkers: C-reactive protein
Description
Change in C-Reactive Protein (CRP) with an at-home blood test after 12 weeks compared to baseline results.
Time Frame
12 weeks
Title
Changes in saliva cortisol levels
Description
Change in saliva cortisol levels with an at-home test after 12 weeks compared to baseline results.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Gender identity
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Susanne Mitschke
Organizational Affiliation
Citruslabs
Official's Role
Principal Investigator
Facility Information:
Facility Name
Citruslabs
City
Santa Monica
State/Province
California
ZIP/Postal Code
90404
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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