Menstrual Pain, Premenstrual Syndrome
Conditions
Keywords
Bloating, Mood Disorders
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.
Interventions
DIETARY_SUPPLEMENTDITTO Cycle 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).
Sponsors
Muse Nutrition Ltd
Citruslabs
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Menstrual Symptoms Questionnaire (MSQ) Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Symptom Severity Ratings | 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. |
| 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) | 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 |
Countries
United States
Outcome results
None listed