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 @ 6:52 PM
Ignite Modification Date:
2025-12-24 @ 6:52 PM
NCT ID:
NCT04084457
Eligibility Criteria:
Inclusion Criteria:
* Participants will include 60 healthy male and female volunteers, aged 65-80.
* Volunteers will be able to understand the nature of the study and able to give signed written informed consent.
* Subjects willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study.
Exclusion Criteria:
* Manifest cardiovascular diseases including coronary artery disease, cerebrovascular disease and peripheral artery disease.
* Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg.
* Obese participants, defined as BMI superior or equal to 30.
* Diabetes mellitus and metabolic syndrome.
* Acute inflammation, terminal renal failure or malignancies.
* Allergies to berries or another significant food allergy.
* Subjects under medication or on vitamin/dietary supplements (within 2 weeks of baseline).
* Subjects who have lost more than 10% of their weight in the past 6 months or are currently on a diet.
* Subjects who reported participant in another study within one month before the study starts.
* Subjects who smoke cigarettes irregularly.
* MCI or dyslexic or unable to complete the cognitive function tasks for any reason such as visual impairments.
* Subjects who require chronic antimicrobial or antiviral treatment.
* Subjects with unstable psychological condition.
* Subjects with history of cancer, myocardial infarction, cerebrovascular incident.
* Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
65 Years
Maximum Age:
80 Years
Study:
NCT04084457
Study Brief:
Protocol Section:
NCT04084457