https://www.linkedin.com/pulse/new-cross-over-clinical-trial-using-fibromyalgia-test-garth-nicolson

New Cross-Over Clinical Trial Using Fibromyalgia Patients to Test Membrane Lipid Replacement in Reducing Pain, Fatigue and Gastrointestinal Symptoms
Published on September 12, 2017

A new clinical trial for patients with fibromyalgia living in central Texas has been approved and is seeking patients, including veterans. This trial, “Membrane Lipid Replacement in Fibromyalgia”, is described below. For more information on MLR see: http://www.immed.org/treatment%20considerations/06.11.2016.update/Clinical_Uses_MLR-NicolsonDiscoveries2016.pdf

Description of the Trial

Cellular energy systems are largely located within the mitochondria in cells. Oxidative and other damage to mitochondrial membrane lipids been associated with loss of function leading to fatigue found in aging and disease. We have found that replacement of damaged membrane lipids through the use of oral supplements has been associated with reductions of fatigue in several small clinical trials.

Trial Design

This new IRB-approved clinical study is to be a randomized, double-blinded, placebo-controlled cross-over trial between FDA-approved membrane lipid wafers (NTFactor Lipids®) and placebo to detect associations between relief of fatigue, pain and other symptoms in patients diagnosed with fibromyalgia. Patients will not have stop taking their current medications to enroll in the trial, which will last approximately 3 months. The diagnosis of fibromyalgia will be confirmed using the American College of Rheumatology criteria. The only “treatment” will be the membrane lipid and placebo wafers.

Participation

Patients interested in this trial may enroll through the web site www.immed.org using the button “Sign up for Clinical Trials,” or call (512) 547-5007.

Garth L. Nicolson, Ph.D., M.D. (H)