Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
Inflammation
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Triple (Participant, Care Provider, Investigator)Primary Purpose: Treatment

Participation Requirements

Age
Between 20 years and 85 years
Gender
Both males and females

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 participant...

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.

Tracking Information

NCT #
NCT03350906
Collaborators
  • National Institute on Aging (NIA)
  • National Center for Research Resources (NCRR)
Investigators
Principal Investigator: Ian R Lanza, MD Mayo Clinic