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 @ 4:41 AM
Ignite Modification Date:
2025-12-25 @ 4:41 AM
NCT ID:
NCT04516018
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent
* Caucasian
* Healthy (as determined by dependent physician based on medical questionnaire)
* Man, or postmenopausal (defined as at least 1year post cessation of menses) woman
* Aged 40 - 75 years at the start of the study
* BMI 27 and 35 kg/m2
* Stable dietary habits (no weight loss or gain \>3kg in the past 3 months)
Exclusion Criteria:
* \- Not meeting all inclusion criteria
* Medication use known to hamper subject's safety during study procedures
* Co-morbidities to which the intervention or program that may pose as a complicating factor
* Subjects diagnosed with cardiovascular diseases or cancer
* Fasting plasma glucose ≥ 7.0 mmol/l
* Haemoglobin \< 7.8 mmol/l for women, or \< 8.4 mmol/l for men
* Previously diagnosed with type 2 diabetes
* Abuse alcohol/drug abuse
* Subjects who do not want to be informed about unexpected medical findings during the screening/study or do not wish that their physician is informed.
* Engagement in structured exercise \> 2h per week
* Participation in another biomedical study within 1 month before the first study
* Smoking
* Cold-acclimated, such as takes daily extended cold baths, works in a refrigerated environment, or regular cold-water swimming within 1 month of starting the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT04516018
Study Brief:
Protocol Section:
NCT04516018