Inflammation Clinical Trial
Official title:
Enhancing Adaptations to Exercise
Verified date | October 2023 |
Source | Mayo Clinic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Researchers are trying to understand how chronic inflammation affects muscle function and responses to exercise.They are also trying to determine if suppressing chronic inflammation using omega-3 fatty acids (n3-PUFA) restores skeletal muscle function and exercise responsiveness in older adults.
Status | Completed |
Enrollment | 63 |
Est. completion date | December 31, 2021 |
Est. primary completion date | December 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 20 Years to 85 Years |
Eligibility | Inclusion criteria: - Men and women between the ages of 20-35 years - Men and women between the ages of 65-85 years Exclusion criteria: - Regular use of omega-3 nutritional supplements - Diabetes or fasting plasma glucose > or equal to 126 mg/dL - Anemia (female subjects hemoglobin of <11 g/dl and male subjects hemoglobin <12 g/dl) - Active coronary artery disease or history of unstable macrovascular disease (unstable angina, myocardial infarction, stroke, and revascularization of coronary, peripheral or carotid artery within 3 months of recruitment) - Renal failure (serum creatinine > 1.5mg/dl) - Chronic active liver disease (AST>144 IU/L or ALT>165 IU/L) - Oral warfarin group medications or history of blood clotting disorders. - international normalized ratio (INR) >2.01.5 - Smoking - Pregnancy or breastfeeding - Alcohol consumption greater than 2 glasses/day or other substance abuse - Untreated or uncontrolled hypothyroidism - Debilitating chronic disease (at the discretion of the investigators) - Fish or shellfish allergy |
Country | Name | City | State |
---|---|---|---|
United States | Mayo Clinic in Rochester | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Mayo Clinic | National Center for Research Resources (NCRR), National Institute on Aging (NIA) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Maximum Workload Muscle Strength | Single-leg knee extensor strength was measured on a pneumatic resistance leg extension machine (Keiser Air300, Keiser Corporation, Fresno, CA, USA) and defined as the unilateral 1-repetition maximum (1-RM). Subjects performed a unilateral knee extension warm-up consisting of 10 repetitions at minimal resistance and 3 sets of 5-10 repetitions at increasing workloads. Subjects then performed a series of single repetition attempts at increasing workloads, each separated by 3 min of rest, until the maximum load that could be moved through the entire range of motion was reached. This maximum workload was defined as the individual 1-RM. | baseline, 6 months | |
Primary | Body Mass Index (BMI) | Subject's BMI calculated as weight in kilograms divided by height in meters squared. Uses measurements of height and weight obtained during study (with appropriate metric conversions). Measured as kg/m^2 | baseline, 6 months | |
Primary | Body Fat | Dexa Scan based body fat, measured as a percentage of body weight | baseline, 6 months | |
Primary | Lean Body Mass | Lean body mass as measured by a DEXA scan is the amount of soft tissue that is not fat or bone. Measured in kilograms. | baseline, 6 months | |
Secondary | C-Reactive Protein (CRP) | C-reactive protein is a substance produced by the liver in response to inflammation. Normal CRP levels are below 3.0 mg/L.Units: mg/L | baseline, 6 months | |
Secondary | Erythrocyte Sedimentation Rate (ESR) | ESR is a blood test that can reveal inflammatory activity in the body. It measures the distance red blood cells fall in a test tube in one hour. The farther the red blood cells have descended, the greater the inflammatory response of the immune system. Normal results: < 16 years: < 10 mm/hr;Male < 50 years: < 15 mm/hr;Male > 50 years: < 20 mm/hr;Female < 50 years: < 20 mm/hr;Female > 50 years: < 30 mm/hr | baseline, 6 months | |
Secondary | Weight | Subjects calculated weight in kilograms | baseline, 6 months |
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