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 @ 9:42 PM
Ignite Modification Date:
2025-12-24 @ 9:42 PM
NCT ID:
NCT02052232
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 60 and ≤ 75 years
* Body Mass Index (BMI) \> 23.0 to \< 30.0
* Ability (with or without the aid of an assistive device) to climb a flight of 10 stairs or walk an equivalent of 1 city block without assistance
* Currently not participating in a formal exercise or training program and agrees to refrain from intense physical activity from screening through the completion of the study.
Exclusion Criteria:
* Diagnosis of diabetes
* Active pursuit of weight loss
* Poorly controlled hypertension or hypotension
* Untreated hypothyroidism or hyperthyroidism
* Anemia or abnormally functioning kidneys or liver
* A significant cardiovascular event within ≤ 6 months; or stated history of congestive heart failure; or evidence of clinically active cardiovascular disease assessed during the screening EKG
* Peripheral arterial disease or other diseases that preclude proper limb blood flow
* Chronic, contagious, infectious disease
* Current infection or corticosteroid treatment within the last 3 months
* Clotting or bleeding disorders, stated history of Deep Vein Thrombosis (DVT) and/or a known hypercoagulable condition
* In condition deemed unsuitable for study based upon study physician assessment
* Surgery requiring \>2 days of hospitalization in the last 3 weeks and/or planned elective surgery requiring \>2 days of hospitalization during the course of the study
* Current active malignant disease or was treated within the last 6 months for cancer
* An amputee
* Obstruction of the gastrointestinal tract, inflammatory bowel disease, short bowel syndrome or other forms of gastrointestinal disease
* Diagnosed with, or has a history of severe dementia or delirium, eating disorder, history of significant neurological or psychiatric disorder, alcoholism, substance abuse
* Cannot refrain from taking
* High doses of fish oil, or omega-3 supplements, or high doses of vitamin D
* Medications/dietary supplements/herbals or substances that are considered anabolic, or reduce weight
* Any pulmonary anti-inflammatory medication or bronchodilators on the day of and 48 hours prior to study visits 1 and 2
* NSAIDS or acetaminophen on the day of and 48 hours prior to study visits 1 and 2
* Chronic use of nicotine
* Allergic or intolerant to any ingredient found in the study products
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT02052232
Study Brief:
Protocol Section:
NCT02052232