At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
The ENRGISE (ENabling Reduction of Low-Grade Inflammation in SEniors) Pilot Study
In Brief
A Phase 2 clinical trial evaluating Omega-3 fish oil, Losartan, and 2 other interventions for Inflammation. Completed, enrolled 289 participants across 5 sites.
Detailed Summary
ENRGISE Pilot Study will test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability.
Study Details
Timeline
Interventions
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.
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.
The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.