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:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-24 @ 10:07 PM
NCT ID:
NCT05220735
Eligibility Criteria:
Inclusion Criteria:
* Self-classified women from African descent and of reproductive age (18 - 35 years)
* BMI ≥ 28kg/m2 (indicating obesity)
* Midly- or non-anaemic (Hb ≥11 g/dl)
* Low n-3 LCPUFA status (RBC omega-3 index \< 6%)
* Low grade systemic inflammation (HS-CRP ≥ 2 mg/l but ≤ 20 mg/l)
* Be able to read and understand English
Exclusion Criteria:
* Treated chronic disease or gastrointestinal disorders
* Regular use of medication (except oral contraceptives, others after approval by the investigator) and women receiving treatment for high blood pressure
* Current consumption of iron or n-3 LCPUFA or ascorbic acid-containing supplements other than the supplements provided (Participants will be asked to discontinue use three weeks prior to enrolment)
* Subject on a weight loss diet or planning to start a weight loss diet during the duration of the study
* Pregnancy or lactation
* Subjects who cannot be expected to comply with the study protocol
* Subjects who are smoking
* Difficulty drawing blood due to poor quality veins
* Individuals that have a fear of needles or suffer from vaso-vagal episodes when exposed to blood
* Subjects with fish allergies
* Participants who plan to start or stop the use of contraceptives in the following 4 months.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
35 Years
Study:
NCT05220735
Study Brief:
Protocol Section:
NCT05220735