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 @ 3:38 AM
Ignite Modification Date:
2025-12-25 @ 3:38 AM
NCT ID:
NCT03197402
Eligibility Criteria:
Inclusion Criteria:
* Females between 70 and 75 years of age (a narrow age range improved homogeneity of the sample for this proof-of-concept trial) with a body mass index (BMI) between 27 and 35, and muscle mass 1 standard deviation below that of sex- and ethnicity-matched 30 year olds (note: this has been called 'stage 1 sarcopenia' or 'pre-sarcopenia') will be recruited. In addition, participants will be non-smokers and generally healthy per responses to a standard health screening questionnaire.
Exclusion Criteria:
* Participants who have any one of the following conditions will be excluded:
* diabetes mellitus
* cardiovascular disease
* renal disease
* gastrointestinal disease
* musculoskeletal injuries
* hormone replacement therapy
* significant weight loss in the 3-month period prior to the study
* vegan diet
* dairy protein allergy
* use of medications known to interfere with muscle metabolism. For example, chronically taking any analgesic or anti-inflammatory drugs(s), prescription or non-prescription
* a history of neuromuscular problems or muscle and/or bone wasting diseases
* any acute or chronic illness, cardiac, pulmonary, liver, or kidney abnormalities, uncontrolled hypertension, insulin- or non-insulin dependent diabetes or other metabolic disorders-all ascertained through medical history screening questionnaires
* use medications known to affect protein metabolism (i.e. corticosteroids, non-steroidal anti-inflammatories, or prescription strength acne medications)
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
70 Years
Maximum Age:
75 Years
Study:
NCT03197402
Study Brief:
Protocol Section:
NCT03197402