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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Premenstrual Syndrome Menstrual Pain

Interventions

DITTO Cycle SupplementDIETARY_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).

Eligibility

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

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

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 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.

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

Secondary Outcomes

Symptom Severity Ratings

Self-report rating of the severity of 13 common menstrual cycle-related symptoms experienced during their most recent menstrual cycle. Each item is scored on a 5-point Likert scale (Not noticeable, Barely noticeable, Moderate, Distracting, Severe). The questionnaire assesses 7 physical symptoms (fatigue, bloating, breast tenderness, headaches, cramps, body aches, food cravings) and 6 psychological symptoms (anxiety, irritability, mood swings, crying spells, concentration difficulties, low mood). Higher scores indicate greater symptom severity.

Time frame: 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

Participants are asked how much they agree or disagree with 18 statements about the test product reducing symptoms, for example: "The test product reduces the severity of my menstrual symptoms", "The test product reduces the duration of my menstrual symptoms", "The test product reduces the amount of mood swings I have related to my period", "The test product reduces my menstrual cramps". Response options: Strongly agree, Agree, Neither agree or disagree, Disagree, Strongly disagree

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

Data from ClinicalTrials.gov

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