Enhancing Adaptations to Exercise

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Inflammation

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03350906

17-004403

R01AG054454 (U.S. NIH Grant/Contract)

UL1RR024150 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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63 participants in 2 patient groups, including a placebo group

n3-PUFA

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Body Composition Scan

Procedure: Biopsy

Drug: n3-PUFA

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Diagnostic Test: Body Composition Scan

Procedure: Biopsy

Drug: Placebo