A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms

Muse Nutrition Ltd40 enrolled

Overview

This is a single-group, virtual clinical trial evaluating the effects of a daily dietary supplement (DITTO Cycle Supplement) on menstrual cycle symptoms across three menstrual cycles. The study investigates changes in symptom severity and quality of life through validated questionnaires including the Menstrual Symptoms Questionnaire (MSQ).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premenstrual Syndrome Menstrual Pain

Interventions

DITTO Cycle SupplementDIETARY_SUPPLEMENT

The capsules should be taken in the morning with the first meal and a glass of water.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female-at-birth * Aged 18-45 * In the last three menstrual cycles, has experienced three or more of the following symptoms associated with their menstrual cycle: Menstrual cramps, Bloating, Breast tenderness, Headaches, Fatigue, Muscle aches and/or joint pain, Cravings, Mood swings, Low mood, Feelings of anxiety, Irritability, Difficulty concentrating * Generally healthy - does not live with any uncontrolled chronic disease * Has a regular menstrual cycle length, between 23 and 35 days * Tracks their menstrual cycle and can predict their period dates * Anyone willing to comply with study requirements * Anyone with no known allergies to the ingredients listed in the product Exclusion Criteria: * Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders * Women who are pregnant, breastfeeding, or trying to conceive * Anyone unwilling to follow the study protocol * Anyone in perimenopause, menopause, or experiencing menopausal-type symptoms * Anyone with planned surgery during the study period * Anyone with a history of substance abuse * Anyone diagnosed with high blood pressure, high cholesterol, heart disease, heart attack, stroke, irregular heartbeat (AFib), clogged arteries, poor circulation, heart failure, or other heart conditions * Anyone diagnosed with a hormone or reproductive health-related cancer or benign condition * Anyone diagnosed with a menstrual health condition such as endometriosis, PCOS, or adenomyosis * Anyone diagnosed with diabetes or other endocrine-related condition * Anyone currently participating or planning to participate in a research study * Anyone who has started, changed, or stopped taking hormonal birth control in the last three months * Has a planned insertion or replacement of an IUD in the next 12 weeks

Locations (1)

Citruslabs

Las Vegas, Nevada, United States

Outcomes

Primary Outcomes

Change in Menstrual Symptoms Questionnaire (MSQ) Scores

Change from baseline in menstrual symptom severity as measured by the Menstrual Symptoms Questionnaire (MSQ), including cramps, bloating, fatigue, mood swings, breast tenderness, headaches, anxiety, irritability, and difficulty concentrating.

Time frame: Baseline, End of Cycle 1(28 days), End of Cycle 2(28 days), End of Cycle 3 (28 days)

Secondary Outcomes

Change in Menstrual-Related Quality of Life

Change from baseline in participant-reported quality of life related to menstrual symptoms, measured using study-specific self-report questionnaires evaluating overall impact on daily living and well-being.

Time frame: Baseline, End of Cycle 1(28 days), End of Cycle 2(28 days), End of Cycle 3 (28 days)

Data from ClinicalTrials.gov

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