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 @ 7:51 PM
Ignite Modification Date:
2025-12-24 @ 7:51 PM
NCT ID:
NCT04300504
Eligibility Criteria:
Inclusion criteria:
* Caucasian
* Female
* BMI 18.5-25 or 30-40kg/m2
* Ages 60-80 years
* Sufficiently mobile to undergo scanning and biomechanical testing
* Able to remain motionless during scans
* Able and willing to participate in the study and provide written informed consent
Exclusion Criteria:
* BMI 18.5-25kg/m2 AND waist circumference \>88cm i.e. normal weight AND abdominally obese
* BMI 30-40kg/m2 AND waist circumference \<88cm i.e. obese AND not abdominally obese
* History of any long-term immobilisation (duration greater than 2 weeks in the past 12 months)
* History of hospital admission in the past 3 months
* History of recent significant weight loss (5% in 3 months or 10% in 6 months)
* Diabetes mellitus
* History of current conditions which may affect muscle metabolism
* Malabsorption syndromes e.g. inflammatory bowel disease, pancreatic insufficiency etc.
* Chronic renal disease
* Diagnosed eating disorder
* Conditions which prevent the undertaking or analysis of the MRI and DXA scans or the interpretation of their results e.g. hip prosthesis, metal implants etc.
* Conditions which prevent the undertaking of the fatigue protocols e.g. hypertension etc.
* Use of medications or treatment known to affect muscle metabolism
o Anabolic steroids, glucocorticoids, antiretrovirals etc.
* Excessive alcohol intake defined as greater than 21 units per week
* Competitive athlete, defined as participating in competitive sport at amateur or professional level
* Conditions which prevent the undertaking of a 6-minute walking test e.g. unstable angina or myocardial infarction during the previous month.
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
60 Years
Maximum Age:
80 Years
Study:
NCT04300504
Study Brief:
Protocol Section:
NCT04300504