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ALS Soy Peptide Trial Completes Enrollment

Brain synapses illustration

(AllanAjifo, Wikimedia Commons)

25 October 2016. A clinical trial testing a peptide found in soy as a potential treatment for amyotrophic lateral sclerosis or ALS completed its enrollment of 50 participants. Participants in the study, conducted at the Duke University ALS Clinic in Durham, were recruited by PatientsLikeMe, a network of patients that encourages participation in clinical trials.

ALS, also known as Lou Gehrig’s disease, is a progressive neurodegenerative disorder where neurons or nerve cells controlling muscles in the body begin to waste away, and can no longer send or receive signals from the brain or spinal cord. As the nerve cells stop functioning, the muscles in the limbs, and later speech and breathing muscles, begin weakening and eventually stop functioning. Most people with the disease die of respiratory failure.

The intermediate-stage clinical trial is testing lunasin, a peptide, or short-chain protein, found in soy and other grains and claimed to have a number of therapeutic effects, including as an anti-inflammatory, anti-oxidant, and anti-hypertensive. ALSUntangled, an organization affiliated with the Duke ALS Clinic that investigates alternative treatments for ALS, found no human clinical studies of lunasin for any disorder, as of September 2014.

Lunasin, however, may affect chemicals in the body that influence the progress of ALS. The peptide appears to activate macrophages, white blood cells in the immune system that take in and reduce free radicals, oxidized molecules attacking and disrupting stable cells in the body. Lunasin also inhibits release of pro-inflammatory enzymes often found in the blood and spinal fluid of people with ALS. In addition, lunasin can change the functioning of histone proteins, molecules released as a result of cell death, that can alter patterns of gene expression related to cell death associated with ALS. Histone functioning and altered gene expression are sometimes targets in ALS clinical studies.

The potential of lunasin with ALS was reported by Richard Bedlack, director of the Duke clinic and founder of ALSUntangled. Mike McDuff, an individual with ALS, took lunasin supplements and noted improvements in speech, swallowing, and limb strength. Bedlack reviewed McDuff’s records, and found no reason to doubt his diagnosis and improvements in functioning.

While Bedlack acknowledged McDuff’s progress may be due to other factors, enough evidence pointed to the possibility of lunasin actually working to reverse ALS symptoms. ALSUntangled received a few other anecdotal reports of lunasin’s effects that could not be systematically verified. In addition, lunasin seems relatively safe for ALS patients.

The clinical trial has a simple design, where the 50 participants — recruited in only 5 months — will take a daily regimen of lunasin and other nutritional supplements, blended together like a milkshake, for 1 year. The muscle functioning of participants will be measured on a standard ALS Functional Rating Scale, at the Duke ALS clinic at 3 intervals over 12 months.

Participants will also take part in a “virtual trial” coordinated by PatientsLikeMe, where they record their own weight and ALS functioning with the same standard scale each month for 12 months. The self-reported data will be matched to reports collected at the Duke clinic. Progress on the standard scale is then compared to participant records maintained by PatientsLikeMe, an organization first founded to assist in clinical trials for ALS.

“We’re taking a completely open approach,” says Bedlack in a PatientsLikeMe statement, “so that anyone, anywhere, can see the details of what we’re testing and learn more about whether this is helpful, harmful, or does nothing at all. I think all of these factors made the trial very attractive to ALS patients.”

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