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

NCT07267728 | Completed

• 1 other identifier: 20736
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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 through validated questionnaires including the Menstrual Symptoms Questionnaire (MSQ), and proportion of participants experiencing symptom reduction.

Conditions

Premenstrual Syndrome; Menstrual Pain

Keywords

Bloating; Mood Disorders

Outcome Measures

Primary Outcomes (1)

• Change in Menstrual Symptoms Questionnaire (MSQ) Scores

  Change from baseline in menstrual symptom severity as measured by the validated 24-item Menstrual Symptoms Questionnaire (MSQ). Rated on a 5-point Likert scale (Never, Rarely, Sometimes, Often, Always). Higher scores indicate greater symptom severity.

  Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation)

Secondary Outcomes (2)

• Symptom Severity Ratings

  Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation)

• Proportion of participants with perceived reduction in menstrual cycle symptoms

  Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation)

Study Arms (1)

DITTO Cycle Supplement

EXPERIMENTAL

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.

Dietary Supplement: DITTO Cycle Supplement

Interventions

DITTO Cycle Supplement DIETARY_SUPPLEMENT

The capsules contain 10 evidence-based ingredients (8 nutrients, 2 extracts) for premenstrual symptoms and period pain. Ingredients are as follows: saffron extract, chamomile oil, vitamin D3 oil, omega 3 DHA and EPA fatty acids (algal oil), iron, zinc, vitamin B6, chromium, vitamin C, magnesium. Capsules should be taken in the morning with the first meal and a glass of water. Capsules are designed with a nutrient delivery biotechnology "beadlet-in-oil).

DITTO Cycle Supplement

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Female-at-birth, generally healthy
• 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
• Natural menstrual cycle or regular withdrawal bleeds if on hormonal contraception
• Has a regular menstrual cycle length, between 21 and 35 days
• Tracks their menstrual cycle and can predict their period dates
• Willing to comply with study requirements
• Willing to refrain from taking any other products, medications, or supplements that target menstrual health during the test period
• No known allergies to the ingredients listed in the product

You may not qualify if:

• Anyone diagnosed with chronic conditions that may affect study outcome (e.g. heart conditions, diabetes, endocrine-related disorders, reproductive health-related cancers)
• 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
• Started, changed, or stopped taking hormonal birth control in the last three months
• Anyone with planned surgery during the study period
• Anyone with a history of substance abuse
• Anyone currently participating or planning to participate in a research study
• Has a planned insertion or replacement of an IUD in the next 12 weeks

Sponsors & Collaborators

• Muse Nutrition Ltd: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Las Vegas, Nevada, 89118, United States

Location

MeSH Terms

Conditions

Premenstrual Syndrome; Dysmenorrhea; Mood Disorders

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 5, 2025
• Study Start: February 1, 2025
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: August 17, 2026

Record last verified: 2026-08

Locations

US (1)