Enhancing Adaptations to Exercise

Phase 3

Completed

Interventions: Drug: n3-PUFA
Drug: Placebo
Procedure: Biopsy
Diagnostic Test: Body Composition Scan

Brief Summary: 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.

Detailed Description: Participants will be divided into two groups. Men and women between the ages of 20-35 years and 65-85 years. Participants in the older age group will be randomly assigned to receive groups (n3-PUFA or placebo (soybean oil)) in a double-blind manner. Before and after the intervention, all participants will complete an outpatient study day (body composition, blood draw, treadmill test, strength test) and an inpatient study day (muscle biopsies, fat biopsies, indirect calorimetry, exercise test, mixed meal test). During the intervention phase of the study, participants will be instructed to swallow 2 softgels twice per day with meals (morning and evening) for a total of 4 softgels per day. Every 4 weeks, participants will report to the Clinical Research and Trials Unit (CRTU) to pick up a new prescription and return any remaining capsules from the previous prescription. On the day they pick up prescription refills, participants will report to the CRTU for a fasting blood sample. The duration of the intervention will be 6 months.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
n3-PUFA	Body Composition Scan	Participants will be instructed to swallow 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.
Placebo	Biopsy	Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.
Placebo	Body Composition Scan	Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.
n3-PUFA	n3-PUFA	Participants will be instructed to swallow 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.
n3-PUFA	Biopsy	Participants will be instructed to swallow 2 Docosahexaenoic acid (DHA)/EPA soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.
Placebo	Placebo	Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day.

Primary Outcome Measures

Name	Time	Method
Body Mass Index (BMI)	baseline, 6 months	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
Lean Body Mass	baseline, 6 months	Lean body mass as measured by a DEXA scan is the amount of soft tissue that is not fat or bone. Measured in kilograms.
Body Fat	baseline, 6 months	Dexa Scan based body fat, measured as a percentage of body weight
Change in Maximum Workload Muscle Strength	baseline, 6 months	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.

Secondary Outcome Measures

Name	Time	Method
C-Reactive Protein (CRP)	baseline, 6 months	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
Erythrocyte Sedimentation Rate (ESR)	baseline, 6 months	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
Weight	baseline, 6 months	Subjects calculated weight in kilograms