A Israeli study has found that multiple sclerosis patients taking a nano-engineered nutritional supplement made out of pomegranate oil showed “significant cognitive improvement” after just three months.
The small-scale study of 30 patients was conducted at the Multiple Sclerosis Center at Hadassah Ein Kerem Hospital in Jerusalem by Prof. Dimitrios Karussis, director of the center and a senior neurologist. Results showed that patients taking the supplement witnessed an average 12 percent improvement in learning ability and text comprehension, word recall and categorization, in the three months of treatment.
The researchers are now writing up the findings to submit them to neurological journals for peer review, Karussis said in a phone interview.
The pomegranate oil supplement the patients were given was developed by Prof. Ruth Gabizon, a researcher of degenerative brain diseases at the Neurology Department of Hadassah University Hospital in Jerusalem, together with Prof. Shlomo Magdassi, an expert in the field of nanotechnology from the Casali Institute for Applied Chemistry at the Hebrew University.
Pomegranate seed oil (PSO) contains high concentrations of punicic acid, or omega 5, which is believed to be one of the most powerful antioxidants in nature.
Common daily activities, such as digesting food and breathing, create free radicals that result in oxidation and damage to human cells, particularly brain cells. Unlike blood or skin cells, brain cells do not get replaced by new ones. So free radicals impair thinking, memory, orientation and alertness, among other abilities.
Degenerative brain disease and brain atrophy are typical of debilitating illnesses such as Alzheimer’s, Parkinson’s, and Creutzfeldt-Jakob disease in which brain cells are destroyed, followed by rapid functional and behavioral deterioration and eventual death.
Aging and brain degeneration are a natural and unavoidable process, but they can be accelerated or slowed down depending on our lifestyles.
Antioxidants are known for their ability to protect against the destruction of brain and body cells. They can be found in foods such as cranberries, blueberries, beans, artichokes, pecans and foods containing Vitamin E.
The problem is that the antioxidants consumed through food and supplements are ingested in too low a concentration to have the desired effect or are broken down in the digestive system, and thus never make it to the brain or other cells.
So, using nanotechnology, Gabizon and Magdassi say, they managed to break down pomegranate oil into tiny particles that are able to escape the liver’s filtering function and thus can make their way to the brain.
The product they developed, called GranaGard, which has a high concentration of antioxidants, has been found effective in lab mice, and two studies were published in the International Journal of Nanomedicine in November 2015 and in the International Journal of Nanomedicine in 2014.
Prof. Karussis’ study is the first to test the effectiveness of the supplement on humans.
As part of the study, the 30 patients were divided into two groups of 15, with one group getting the nano-engineered omega 5 acid supplement, and the other one getting a placebo. The study was a double blind one, meaning that both the doctors and the patients didn’t know who was getting the pills and who the placebo.
The patients were in a “progressive” or moderate stage of the disease, Karussis said, at a level five out of nine degrees of severity. “These were patients that already had a significant neurological impairment,” he said, and were suffering from the disease for over 10 years.
Multiple sclerosis is a disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged. This disrupts the ability of parts of the nervous system to transmit signals, causing a variety of physical and mental problems.
Patients can suffer from blindness and muscle weakness and trouble with sensation and coordination. A change in cognitive function is common in MS, and more than half of all people with MS will develop problems with information processing, memory, attention and concentration, visual perception and word finding.
Many of the treatments offered to MS patients affect their motoric and sensory abilities, said Karussis, but do not address their cognitive abilities.
“The drugs we give generally aim to depress an inflammatory process, but together with this there is also a degeneration process that happens, caused by the death of nerve cells,” he said. “To avoid this death you need other things, like for example something that works as an antioxidant,” because oxidation is one of the main factors for nerve cell death.
The average 12% improvement in cognitive functions showed by the patients “is significant” he said. In some of the tests performed to assess the variety of functions, patients scored between 20% and 30%, he added.
No improvement or change was observed among subjects participating in the control group. At the end of the study, it was found that the improvement was maintained for at least three months.
“The indication in the tests was all in one direction,” he said.
Karussis said he knows the developers of the supplement, Gabizon and Magdassi, but the study was undertaken independently and he has no connection or financial interests in the firm set up by Gabizon to market the product. Karussis has published more than 120 peer-reviewed scientific papers, mostly in the field of neuroimmunology and stem cells, and is considered one of the world experts in the field of clinical applications of stem cells in neurological diseases.
He added that although the study was on the impact of the supplement on the cognitive function of MS patients, this provides a “logical basis to think” that the supplement could also work on improving the cognitive faculties of patients with Alzheimer’s or other neurodegenerative diseases.
Karussis said he would recommend the supplement to people who are cognitively impaired, because it can be an “important addition” to prevent the death of neurons.
He said that the study was on a small scale because of cost constraints.
“We normally begin with a pilot study, an initial study. And then we can do something bigger if need be. Our aim is to get what is called a proof of concept that proves the idea,” he said.
“You get to a proof of concept when you are sure of results, and here we are getting a significant indication” of success, which means there is reason to recommend the supplement as an addition to treatment for people with cognitive degeneration. “I would be happy to see also a bigger study that will prove this in an unambiguous way.”
“This trial represents a scientific breakthrough in treating cognitive impairment resulting from brain cell destruction using natural antioxidants,” said Gabizon in a phone interview. She added that the supplement can also help older people who are stuck at home under lockdown, due to the coronavirus pandemic, to maintain their cognitive abilities.
These older people are alone at home without the stimulus of a social circle or family, and this can cause a deterioration of their cognitive faculties, she said, causing memory problems or even depression.
The company, Granalix Biotechnologies Ltd., sells its products directly to customers in Israel and abroad online and via distributors in Mexico, Paraguay and Greece. The firm is about to start a second clinical study with Rambam Hospital in Haifa to study the impact of the supplement on moderate and mild cognitive impairment of people with dementia, Gabizon said.