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:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02397304
Eligibility Criteria:
* Anthropometry/Body Size:
i. Overweight (White European populations, BMI 25-29.9 kg/m2 or Asian populations, BMI 23-27.4 kg/m2) and have a high waist circumference (European, Sub-Saharan Africans and Eastern Mediterranean and middle east \[Arab\] men ≥ 94 cm \[37 inches\], women ≥ 80 cm \[31.5 inches\]; South Asian, Chinese, Japanese, and ethnic south and central Americans men ≥ 90 cm \[35 inches\], women ≥ 80 cm \[31.5 inches\]) or ii. Class I obesity (White European populations, BMI 30-34.9 kg/m2 or Asian populations, BMI 27.5-35 kg/m2).
* Weight stable i.e. (±2 kg) for \>3 months before enrolment
* Sedentary i.e. no regular engagement in physical activity
* Diagnosis and general health: Good general health defined as no known cardiovascular or metabolic disease
* Compliance: understands and is willing, able and likely to comply with all study procedures and restrictions
* Consent: demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent.
Exclusion Criteria:
* Answering "YES" to any question on the Screening Form
* Hypertension (≥140/90 mmHg)
* Any ECG Abnormalities
* Current participation in another clinical study
* Current or recent smoker (last 30 days)
* Past history of substance abuse, engagement in uncommon eating practices (e.g., sustained periods of fasting) and taking prescription or non-prescription medication (e.g., beta-blockers, insulin or thyroxine) or supplements that may influence normal metabolic responses.
* Participants who have previously (within 5 years of the present study) had 4 or more muscle biopsies obtained from the thigh quadriceps region will be ineligible
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
49 Years
Study:
NCT02397304
Study Brief:
Protocol Section:
NCT02397304