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:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT01698294
Eligibility Criteria:
Inclusion Criteria:
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure
* Participant must be a non-Hispanic white or non-Hispanic black (self-reported race) woman 45 to 80 years of age and postmenopausal; postmenopausal will be defined as no menstrual cycle in the past 12 months; women with a hysterectomy but with intact ovaries will be included if aged \>= 55 years
* Willingness to comply with the requirements of the study
Exclusion Criteria:
* Unwilling or unable to follow protocol requirements
* Self-reported race other than non-Hispanic white or non-Hispanic black
* Use, in the 2 months prior to week 1 visit, of antibiotics, hormone replacement therapy, nonprescription hormones or herbal supplements for menopausal symptoms, or flaxseed supplements
* Nut or seed allergy
* Self-reported inflammatory bowel disease
* Gastric bypass
* Use of thyroid replacement medication (Synthroid or similar) for \< 1 year
* Any condition which in the investigator's opinion deems the participant an unsuitable candidate to receive flaxseed
* Chemotherapy/radiation within the past year
* Body weight greater than 400 pounds (limit of Tanita scale)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
45 Years
Maximum Age:
80 Years
Study:
NCT01698294
Study Brief:
Protocol Section:
NCT01698294