Research results: Soy products show no benefit in reducing dystrophic symptoms in mdx mice
In 2016, Duchenne UK asked Prof Steve Winder at The University of Sheffield to investigate a nutritional supplement, a soy product, called Haelan 951.
Many in the DMD community take this as a drink, based on anecdotal evidence of benefit for DMD patients. It is expensive and unpleasant to taste. So, we wanted to test it properly to see if we can get scientific evidence to show any significant benefit for patients with DMD.
Our research found that there was NO significant benefit to the muscle in taking the supplement.
We want to share the results with the DMD community as soon as we can, so that families can make more of an informed decision about whether or not to use the supplement.
Prof Winder published a short report on his initial work on Haelan 951 in a scientific journal. He intends to publish his further research in to BBI so that it is available to the wider scientific community.
Background to the project:
The health benefits of soy products have been recognised for centuries, with anecdotal and scientific evidence of beneficial effects from diabetes and cancer to heart disease and inflammation. It has nutritional value – high in amino acids, essential fatty acids and vitamins. It also contains significant amounts of something called Bowman-Birk Inhibitor (BBI). But – it is unpleasant to take and at around £40 per day (£15,000 per year) it’s expensive.
In 2016, Duchenne UK asked Prof Steve Winder at the University of Sheffield to do some work for us to look properly at Haelan 951 to see if it, or some of its constituents, had any impact on a functional measure in mdx mice, a mouse model of DMD. In particular we were interested in the constituents BBI and an isoflavone compound called genestein. This small study produced some interesting results. We asked Prof Winder if he would tell us what he found:
An Interview with Prof Steve Winder
DUK: Prof Winder, please tell us about the study?
Prof Winder: We first carried out a small study looking at the effects of a single dose of Haelan 951, or the equivalent amounts of genistein and BBI on the ability of mdx mice to be able to hang on to a wire. This wire hanging test is a measure of strength and stamina. This study found that if we gave Haelan 951, genestein or genestein with BBI (in the food given to the mice) then there was no difference in their ability to hang on to a wire compared to mice just given a regular diet – their strength and stamina seemed unaffected. However, when we gave BBI alone to mice there was an improvement in their ability to hold on to the wire for longer. It seemed from this data that BBI improved the strength and stamina of the mice.
DUK: Please tell us about the further study you then carried out?
Prof Winder: We needed to try different doses and use more animals so that we can have more confidence in the results – we were looking for statistical evidence of an effect. Also, we wanted to look at more potential effects of BBI.
So, we designed a set of experiments to see whether BBI has a dose-dependent effect in improving dystrophic muscle pathophysiology. We looked at increasing doses regimen of BBI over a 10-week period in mdx mice and we checked their ‘strength and stamina’. We also wanted to look at whether we could see any proteins or other ‘markers of activity’ in the blood of these mice. Additionally, we looked microscopically at the muscles of the mice at the end of the experiments to see if we could see any changes in the muscles.
DUK: Were you able to show effects as you had before?
Prof Winder: In this case, we could not reproduce what we had seen before in any of the ‘strength’ tests. No matter what dose of BBI we gave (and we went ten times lower, and ten times higher than we did in the original study, as well as giving the same dose again) we just didn’t see an improvement in their ability to hold on to wire.
DUK: Do you have any answer as to why, and did you see anything else in the study?
Prof Winder: As to why – we don’t know. Sometimes, when you do an experiment and use a small number of animals you can be ‘fooled’ into thinking you are seeing something real. When you re-test, use more doses and more animals that effect can ‘disappear’. This happens in clinical trials too – early studies may seem promising, but higher numbers can lessen the effect. We have to believe the data we get - we did the work very carefully, and the statistical analysis suggests there was no positive effect.
As to any other effects, the only thing we saw was that under the microscope, the muscle fibres looked slightly ‘fuller’ – but as we didn’t see a related functional effect, we can’t say what, if anything, this means.
DUK: Is there anything positive that has come out of this study?
Prof Winder: All well-conducted science is positive, its just some times you don’t get the answer you predicted or are hoping for. But, we are confident this is the ‘right’ answer and one we can trust. So when we publish the data in a scientific journal, this result will inform other scientists and perhaps help them avoid unnecessarily doing more work in this nutritional area.
One could also argue that continued expensive use of Haelan 951 might not be for the best and will certainly reduce the amount of distaste involved in taking it!
DUK: Thanks, Prof Winder – we appreciate your time.
Prof Winder: Thank you, my pleasure.
If you have any questions, please email [email protected]