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

Muse Nutrition Ltd

Status: Completed

Conditions: Menstrual Pain; Premenstrual Syndrome

Treatments: Dietary Supplement: DITTO Cycle Supplement

Study type: Interventional

Funder types: Industry

Identifiers

NCT07267728

20736

Details and patient eligibility

About

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).

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

DITTO Cycle Supplement

Experimental group

Description:

Participants will take two capsules of the DITTO Cycle Supplement once daily, starting two days after menstrual bleeding ends, for the duration of three menstrual cycles.

Treatment:

Dietary Supplement: DITTO Cycle Supplement