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

Summary

ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability.

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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Abbott

  collaborator INDUSTRY

• University of Florida

  lead OTHER

Principal Investigators

• Marco Pahor, MD · University of Florida

• Walter Ambrosius, PhD · Wake Forest University

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-04-26

Primary Completion

2018-06-22

Completion

2018-06-22

FDA Drug

Yes

Countries

• United States

Study Locations