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 @ 4:16 AM
Ignite Modification Date:
2025-12-25 @ 4:16 AM
NCT ID:
NCT03585920
Eligibility Criteria:
Inclusion Criteria:
* Men and women
* Aged 18-70 years
* Body mass index (BMI): 18-32 kg/m2
* Fasting glucose \< 7 mmol/l
* Fasting total cholesterol \< 7.5 mmol/L
* Fasting triglycerides \< 2.3 mmol/L
* Weight stable in the last three months
Exclusion Criteria:
* Diagnosed with diabetes or cardiovascular disease (e.g. stroke or heart attack), gastrointestinal (e.g. Irritable bowel syndrome (IBS), inflammatory conditions, gastroenteritis), endocrine or renal diseases
* Smoker
* Taking prescribed medications that could influence study outcomes (e.g. lipid lowering medications, anti-depressants, anticoagulants)
* Food allergies (e.g. gluten, dairy) and intolerances (e.g. lactose)
* Drug abuse
* Anaemia (men: haemoglobin\<130 g/L and women \<115 g/L)
* Hypertension (systolic blood pressure \> 140 mmHg, diastolic blood pressure \> 90 mmHg)
* Planning or currently on a weight reducing programme
* Pregnancy, planned pregnancy in the next year or lactating
* Currently taking part or participation in other research studies within the last three months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03585920
Study Brief:
Protocol Section:
NCT03585920