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Clinical Trial

4/28/2021

2016-2018

DGCG

289

N/A

N/A

N/A

Objectives

The ENabling Reduction of low-Grade Inflammation in SEniors (ENRGISE) pilot study was conducted to test whether omega-3 fish oil and the angiotensin receptor blocker losartan alone or in combination can reduce inflammation and improve walking speed in older adults with mobility impairment.

Background

Preserving mobility is essential to maintaining a high quality of life and independent living in the community. Low-grade chronic inflammation depicted through plasma elevation of C-reactive protein, tumor necrosis factor-alpha (TNF-alpha), and particularly interleukin-6 (IL-6), is an independent risk factor for disability, impaired mobility, and slow walking speed. It is unclear, however, whether interventions that reduce the levels of inflammatory markers per se improve mobility or prevent decline in mobility in older persons.

Study Design

This multicenter double-blind placebo controlled three strata clinical trial enrolled participants between April 2016 and June 2017. Participants were 70 years and over, with mobility impairment, had IL-6 between 2.5 and 30pg/mL, and had a 4 m walking speed at usual pace of less than 1 m/s but were able to complete the 400 m walk at baseline.

Interventions/Treatment Groups

Participants (96% of goal) were randomized in three strata 2 x 2 factorial to: a) Losartan 50-100 mg/d or placebo (n =43); b) Fish oil 1,400-2,800 mg/d or placebo (n =180); and, c) with both (n = 66).

Outcomes

A total of two hundred eighty-nine participants mean age 78.3 years, included 47.4 women, 17% black. No effect of losartan or fish oil on the log of IL-6 was observed. Similarly, no effect of losartan or fish oil was seen on walking speed (m/s).

Results/Conclusions

The results of the ENRGISE pilot do not support the use of the study interventions to prevent mobility loss in older adults at risk of disability with low-grade chronic inflammation.
Resources Available
Specimens and Study Datasets
Materials Available

Packed Cells
PBMC
Plasma
Serum