Enhancing Adaptations to Exercise
Overview
- Phase
- Phase 3
- Intervention
- n3-PUFA
- Conditions
- Inflammation
- Sponsor
- Mayo Clinic
- Enrollment
- 63
- Locations
- 1
- Primary Endpoint
- Body Mass Index (BMI)
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Ian R. Lanza
Associate Professor of Medicine
Mayo Clinic
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
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.
Intervention: 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.
Intervention: Biopsy
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.
Intervention: Body Composition Scan
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.
Intervention: 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.
Intervention: Biopsy
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.
Intervention: Body Composition Scan
Outcomes
Primary Outcomes
Body Mass Index (BMI)
Time Frame: 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
Time Frame: 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
Time Frame: baseline, 6 months
Dexa Scan based body fat, measured as a percentage of body weight
Change in Maximum Workload Muscle Strength
Time Frame: 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 Outcomes
- C-Reactive Protein (CRP)(baseline, 6 months)
- Erythrocyte Sedimentation Rate (ESR)(baseline, 6 months)
- Weight(baseline, 6 months)