Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07361757
Eligibility Criteria:
Inclusion criteria:
1. Provide voluntary, written, informed consent to participate in the study
2. Agree to provide a valid cell phone number and are willing to receive communications through text
3. Can read and write English
4. Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
5. Willing to complete questionnaires, records, and diaries associated with the study
6. Healthy female participants ages 40-55 with menopause symptoms but not yet in menopause (period within last 12 months)
7. MRS total score ≥ 5 (preference given to higher score)
Exclusion criteria:
1. Women who are pregnant, breastfeeding, or planning to become pregnant or start breastfeeding during the trial
2. Known food intolerances/allergy to any ingredients in the product
3. Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
4. Having had a significant cardiovascular event in the past 6 months
5. Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
6. On immunosuppressive therapy
7. Having had surgery within the past 6 weeks or upcoming planned surgery in the next few months
8. Adults lacking capacity to consent
9. Post-menopause (≥12 consecutive months without a period)
10. Taking medications: hormone replacement therapy; oral contraceptives; selective estrogen receptor modulators/aromatase inhibitors (e.g., Tamoxifen); sedatives/anxiolytics; blood thinners; insulin
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
55 Years
Study:
NCT07361757
Study Brief:
Protocol Section:
NCT07361757