Clinical trial NCT03350906: Enhancing Adaptations to Exercise
Official title: Enhancing Adaptations to Exercise
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Inflammation
Keywords: Exercise
muscle function
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: National Center for Research Resources (NCRR)
First posted: 2017-11-22
Enrollment: 63
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Maximum Workload Muscle Strength
timeFrame: baseline, 6 months
measure: Body Mass Index (BMI)
timeFrame: baseline, 6 months
measure: Body Fat
timeFrame: baseline, 6 months
measure: Lean Body Mass
timeFrame: baseline, 6 months
Secondary outcomes:
measure: C-Reactive Protein (CRP)
timeFrame: baseline, 6 months
measure: Erythrocyte Sedimentation Rate (ESR)
timeFrame: baseline, 6 months
measure: Weight
timeFrame: baseline, 6 months
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ian R Lanza, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Moosavi D, Vuckovic I, Kunz HE, Lanza IR. A Randomized Trial of omega-3 Fatty Acid Supplementation and Circulating Lipoprotein Subclasses in Healthy Older Adults. J Nutr. 2022 Jul 6;152(7):1675-1689. doi: 10.1093/jn/nxac084.