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Completed

NCT Number: NCT07267728

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

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.

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Key information

Conditions

Premenstrual Syndrome Dysmenorrhea Menstrual Pain Menstruation Disturbances Mental Disorders Mood Disorders Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Pelvic Pain Signs and Symptoms

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Citruslabs

Las Vegas, Nevada, 89118, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

  1. Change in Menstrual Symptoms Questionnaire (MSQ) Scores

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

    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.

Secondary outcomes

  1. Symptom Severity Ratings

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

    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.

  2. Proportion of participants with perceived reduction in menstrual cycle symptoms

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

    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

Sponsors and collaborators

Lead sponsor

Muse Nutrition Ltd

Industry

Collaborators

  • Citruslabs

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 5, 2025
Registry last updated
Aug 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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