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 @ 2:06 AM
Ignite Modification Date:
2025-12-25 @ 2:06 AM
NCT ID:
NCT04364360
Eligibility Criteria:
Inclusion Criteria:
* Participant is willing and able to give informed consent for participation in the study.
* Healthy adults, Male or Female, aged 18 to 65 years.
* No medical condition or relevant drug therapy known to affect glucose or fatty acid metabolism.
* Weight stable for the previous 3 months. -
Exclusion Criteria:
* Aged ≤18 or ≥65 years.
* Body Mass Index ≤19 or ≥35kg/m2.
* Females with a body mass ≤50kg.
* A blood haemoglobin \<135mg/dL for men and \<120mg/dL for women.
* Donated (or lost) ≥250 ml of blood in the previous two months.
* On a weight loss diet or have decreased their body weight by \>5% in the previous 3 months.
* Have increased their body weight by \>5% in the previous 3 months.
* Any metabolic condition or relevant drug therapy known to affect glucose or fatty acid metabolism.
* Smoking, or use of nicotine replacement agents (e.g. e-cigarettes).
* History of alcoholism or a greater than recommended alcohol intake (\>30 g of alcohol daily for men and \>20 g of alcohol daily for women).
* Current or history of Haemorrhagic disorders.
* History of albumin allergy or allergic to eggs
* Current or history of anticoagulant treatment.
* Pregnant or nursing mothers.
* Women prescribed any hormone replacement therapy (HRT) or who have used these within the last 12 months.
* History of severe claustrophobia.
* Presence of metallic implants, pacemaker, or inability/unwillingness to remove any piercings, and any large tattoos around the area to be scanned.
* History or current psychiatric illness.
* History or current neurological condition (e.g. epilepsy).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04364360
Study Brief:
Protocol Section:
NCT04364360