The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study

PHASE2CompletedINTERVENTIONAL
Enrollment

289

Participants

Timeline

Start Date

April 26, 2016

Primary Completion Date

June 22, 2018

Study Completion Date

June 22, 2018

Conditions
Inflammation
Interventions
DIETARY_SUPPLEMENT

Omega-3 fish oil

The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.

DRUG

Losartan

The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by \>40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.

OTHER

Corn Oil (Fish oil Placebo)

The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.

OTHER

Cellulose Based (Losartan Placebo)

The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.

Trial Locations (5)

15213

University of Pittsburgh, Pittsburgh

27157

Wake Forest University, Winston-Salem

32611

University of Florida, Gainesville

60611

Northwestern University, Chicago

02111

Tufts University, Boston

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Institute on Aging (NIA)

NIH

collaborator

Abbott

INDUSTRY

lead

University of Florida

OTHER