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

Study Overview:

Growing evidence shows that low-grade chronic inflammation, characterized by elevations in plasma Creactive protein, tumor necrosis factor alpha, and particularly Interleukin-6 (IL-6), is an independent risk factor of disability, impaired mobility, and lower walking speed. Low-grade chronic inflammation is a modifiable risk factor. However, it is unknown whether interventions that reduce the levels of inflammatory markers per se improve mobility, or avert decline in mobility in older persons.

To address this gap in evidence we conduct the randomized clinical trial ENRGISE (ENabling Reduction of low-Grade Inflammation in SEniors) Pilot Study to test the ability of anti-inflammatory interventions for preventing major mobility disability by improving or preserving walking ability. We have maximized the public health impact by selecting interventions that are safe, tolerable, acceptable, and affordable for vulnerable older persons. Specifically, in this trial we test the efficacy vs. placebo of the angiotensin receptor blocker losartan and omega-3 polyunsaturated fatty acids in the form of fish oil, alone and in combination. Both angiotensin receptor blockers and omega-3 polyunsaturated fatty acids have shown to reduce IL-6 in clinical trials and preliminary data suggest that they may improve physical function.

The aims are to:

  1. Assess the effects of losartan, omega-3, and losartan+omega-3 on IL-6 and walking speed, as compared to placebo.
  2. Address specific questions regarding the conduct of the main randomized controlled trial.
  3. Measure novel and established inflammatory markers

ENRGISE addresses critical public health issues regarding mobility disability prevention. We test the anti-inflammatory effects of widely available inexpensive interventions and their impact on mobility in a highly vulnerable population of older adults at risk of mobility disability.

Coordinating Center Contact

University of Florida Institute on Aging
P. O. Box 100107
Gainesville, FL 32610
352.265-7227
352.265-7228 (Fax)
enrgiseacc@aging.ufl.edu
www.aging.ufl.edu