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 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT03448094
Eligibility Criteria:
Inclusion Criteria:
* Interested in taking part in the study
* Healthy
* Aged 35-60 years (inclusive)
* Have a BMI of between 25-39.9
* Willing to consume your normal diet during the 12 week supplementation period
Exclusion Criteria:
You should not take part if you:
* Are aged under 35 or over 60
* Have a Body Mass Index (BMI) lower than 25 or higher than 39.9.
* Have taken antibiotics (including pre- and pro-biotic supplements/drinks) during the previous 8 weeks
* Have irregular bowel movements (less than 1 per day)
* Have any pre-existing medical conditions/illness with some exceptions - please check with the researcher
* Have type 1 or type 2 diabetes
* Are currently taking prescription medications with some exceptions- please check with the researcher
* Have a visual impairment that cannot be corrected by glasses or contact lenses, including colour blindness.
* English is not your first language or your English proficiency is not equivalent to the International English language test system (IELTS) band 6 or above
* Have any learning difficulties or dyslexia
* Currently suffer from frequent migraines that require medication (\>1 per month)
* Have any food allergies, intolerances or sensitivities
* Have high blood pressure (systolic over 159 mm Hg or diastolic over 99 mm Hg)
* Smoke
* Have a history of alcohol or drug abuse
* Are pregnant, seeking to become pregnant or lactating
* Are unable to complete all of the study assessments
* Are currently participating in any other clinical or nutritional intervention study, or have done within the past 4 weeks
* Have any health condition that would prevent fulfilment of the study requirements
* Have habitually used supplements within the last month (defined as more than 3 consecutive days or 4 days in total)
* Have an excessive caffeine intake (\>500mg per day) - equivalent to 5/6 cups of coffee/8 cups of tea per day or equivalent from other sources
* Consume more than 5 portions of fruit or vegetables per day
* Any sleep disturbances or take sleep aid medication
* Have any known active infections
* You have or may think you are at risk of having syphilis, hepatitis, the Human T - lymphotropic virus or the Human Immunodeficiency Virus?
* You have ever had breast cancer and/or a mastectomy
* You have haemophilia or any similar clotting disorder
* Do not have a bank account (required for payment)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
60 Years
Study:
NCT03448094
Study Brief:
Protocol Section:
NCT03448094