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 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 12:28 AM
NCT ID:
NCT04182867
Eligibility Criteria:
Inclusion Criteria:
* Current night shift worker (defined as a period of work between 11pm and 6am) working regular blocks of 3 night shifts.
* Body mass index between 18.5 and 35 kg/m2.
* Weight stable (no weight change by more than 3 kg in the last 2 months).
* Not a regular smoker (1 or more cigarettes per day) and would be willing not to smoke for the duration of the study.
* Not pregnant or breastfeeding.
* Not diagnosed with heart attack, stroke, angina, thrombosis, liver or kidney diseases, diabetes, chronic gastrointestinal disorder or cancer.
* Not currently taking medication to stabilize blood glucose (e.g. acarbose, metformin or sulfonylureas).
* Not started new medication within the last 3 months likely to interfere with energy metabolism, appetite regulation and hormonal balance, including: anti-inflammatory drugs or steroids, antibiotics, androgens, phenytoin, erythromycin or thyroid hormones.
* Do not take medication for blood pressure e.g. diuretics, (beta-blockers, Ca-channel, ACE inhibitors, Angiotensin Receptor blockers)
* Do not have diagnosed hypertension (high blood pressure, systolic blood pressure that is higher than 180 mmHg and or diastolic blood pressure that is higher than 110 mmHg).
* Not diagnosed with arterial fibrillation or any other condition that affects heart rate (e.g. arrhythmia).
* No food intolerance, allergies, hypersensitivity or follow any dietary restrictions (e.g. gluten intolerance, coeliac, lactose intolerance, vegan or vegetarian) that will prevent the ability to follow the test diets.
* Do not have a history substance abuse, or current high alcohol intake (\>28 units/week for males and \>21 units/week for females).
* Able to understand the information sheet and willing to comply with study protocol and able to follow dietary instructions before and during the study.
* Ability to prepare basic meals from ingredients provided.
* No travel arrangements outside UK within the period of data collection.
* Not already participating in a clinical trial.
* Able to give informed written consent.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT04182867
Study Brief:
Protocol Section:
NCT04182867