Premenstrual SyndromeNCT07267728
A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms
A study testing DITTO Cycle Supplement in people with Premenstrual Syndrome and Menstrual Pain, run by Muse Nutrition Ltd at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Menstrual Pain
- What is being tested?
- DITTO Cycle Supplement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- DITTO Cycle Supplement
- Keywords
- Bloating, Mood Disorders
- Medical subject headings
- Premenstrual Syndrome, Dysmenorrhea, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: DITTO Cycle Supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation)
Secondary outcomes (2)
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.
Measured: 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
Measured: Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2025
- Study start1 Feb 2025
- Primary completion1 Jul 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muse Nutrition Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07267728
- Sponsor's protocol ID
- 20736
- Status last verified
- Aug 2026
- First submitted
- 19 Nov 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Smith M, Mitschke S, van der Schoot A. Self-Reported Changes in Premenstrual and Menstrual Symptoms among Females Taking a Novel Multinutrient Supplement: A Pilot Study. Curr Dev Nutr. 2026 Aug 8;10(9):109511. doi: 10.1016/j.cdnut.2026.109511. eCollection 2026 Sep.
PubMed 42699717
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Effect of a Dietary Supplement on Menstrual Cycle Symptoms
- ClinicalTrials.gov ID
- NCT07267728
- Acronym / sponsor ID
- 20736
- Conditions
- Premenstrual Syndrome, Menstrual Pain
- Keywords
- Bloating, Mood Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muse Nutrition LtdIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jul 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 5 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DITTO Cycle Supplement | Experimental | Dietary Supplement: DITTO Cycle SupplementParticipants 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DITTO Cycle SupplementThe 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). | Dietary supplement | DITTO Cycle Supplement |
Primary outcome
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.
2 secondary outcomes
Symptom Severity Ratings
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
Time frame: Baseline, Menstrual Cycle 1, Menstrual Cycle 2, Menstrual Cycle 3 (each measured 2 days following menstruation)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Derived from this study: PubMed 42699717Smith M, Mitschke S, van der Schoot A. Self-Reported Changes in Premenstrual and Menstrual Symptoms among Females Taking a Novel Multinutrient Supplement: A Pilot Study. Curr Dev Nutr. 2026 Aug 8;10(9):109511. doi: 10.1016/j.cdnut.2026.109511. eCollection 2026 Sep.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DITTO Cycle Supplement in people with Premenstrual Syndrome and Menstrual Pain, run by Muse Nutrition Ltd at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07267728, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.