Widespread media coverage has been given to the launch of a new pill to prevent heart disease and stroke. The Sun said the pill, called Ateronon, “could save thousands of lives”. The Daily Telegraph said that the new product contains lycopene, a natural compound found in tomatoes that is a powerful antioxidant. The newspaper said the compound prevents cholesterol and the build-up of fatty (atherosclerotic) deposits in arteries.
These newspaper stories are based on the release of a new food supplement, the active ingredient of which is lycopene, a compound found in some red-skinned fruit including tomatoes.
There is some evidence to suggest that a Mediterranean-style diet, which is rich in tomatoes, is associated with a reduced risk of heart disease and some cancers in humans, while laboratory and animal studies have found the compound to have antioxidant effects. However, it is difficult to attribute the benefits seen in humans solely to the effects of lycopene. This can only be confirmed by a well-conducted randomised controlled trial.
In addition, one small study appears to suggest that eating enough tomato paste provides similar levels of lycopene in the body.
What is the pill supposed to do?
The manufacturer claims that the pill can reduce the risk of a build-up of fat and cholesterol (plaques) in the arteries. Plaques in blood vessels are linked to heart attacks and strokes.
How is it supposed to do this?
The manufacturer says the pill contains lycopene, which it claims is “one of the most potent natural antioxidants found in the health-promoting Mediterranean diet”. Lycopene is a naturally occurring red pigment found mainly in plants. It is found in greater concentrations in the skins of tomatoes and some other red fruits. Our body’s ability to absorb lycopene from foods depends on whether the foods are processed, raw or cooked.
The manufacturer says that, “in its raw form, lycopene is composed of large liquid molecular crystals that are difficult for the body to absorb and therefore use”. They claim to have found a way to “break down the larger lycopene crystals so that they are more easily absorbed by the body.” The supplement is supposed to reduce “lipoprotein oxidation”, which they say is a leading cause of atherosclerosis, heart attacks and strokes.
Have the health benefits of lycopene been clinically proven, as has been claimed?
The active ingredient in the pill is listed as lycopene. Laboratory and animal studies have shown that a tomato-rich diet increases lycopene levels in the blood, while others have found lycopene has antioxidant effects.
Studies in humans have linked a Mediterranean-style diet, which is rich in tomatoes, to a reduced risk of heart disease and some cancers. For example, the European Prospective Investigation into Cancer and Nutrition study found that the risk of prostate cancer might be reduced by a diet with regular servings of tomatoes. However, a Mediterranean-style diet has many components, and tomatoes are rich in vitamins and other carotenoids that may also be responsible for the effect. It is difficult to attribute the benefits seen in human studies solely to lycopene. This can only be confirmed with a well-conducted randomised controlled trial.
What is the evidence that the pill works?
The Daily Express mentioned a study in 150 people with heart disease, which apparently resulted in a reduction of their blood lipid levels to almost zero in just eight weeks. At present, this research does not appear to be available for review and it is not clear where it was conducted or whether it has been published.
Formal research into the benefits of Ateronon appears to be at an early stage. A report by Professor Alf A Lindberg, which was written for the manufacturers Cambridge Theranostics Ltd in December 2006, describes a small phase I study in 18 people with angina. The patients were given daily doses of lactolycopene (the active ingredient of Ateronon) in tablet form for two months, after which they completed a questionnaire about the severity of their symptoms (angina or chest pain). The results showed that the patients rated their symptoms to have improved after treatment. Tests also showed them to have reduced levels of the lipid oxidation that can lead to the formation of fatty deposits in blood vessels.
However, the study had no control group to which the participants could be compared. As such, it is not clear whether the patients’ symptoms would have improved naturally over time anyway, or whether their expectations of the effects of Ateronon affected how they rated their symptoms. It is unclear from the report whether this study has been published and it may in fact be one of two uncontrolled studies discussed below.
Ateronon is marketed as a food supplement and so does not need approval by the Medicines and Healthcare products Regulatory Agency (the UK drug watchdog). However, EU regulation states that food supplements making health claims must be supported by relevant research. In their application for approval, the manufacturers mention two small, uncontrolled studies in people with coronary heart disease (12 and 10 people respectively). These unpublished studies reportedly demonstrate that lactolycopene supplements had antioxidant properties.
As these studies are unpublished there is limited information about their quality. However, both studies reportedly do not have comparison groups. This means it is not possible to conclude that this antioxidant activity is any different from what would happen by eating tomato products, or whether the changes would have happened anyway, regardless of treatment.
What is lactolycopene and how is it involved?
The manufacturers say that Ateronon makes use of “innovations originally identified by Nestlé”, who developed lactolycopene, a combination of lycopene and whey protein.
A study on lactolycopene was published by Dr Myriam Richelle and colleagues from Nestlé Research Centre and the Centre Hospitalier Universitaire Vaudois in Switzerland. It described 33 healthy people who were randomly allocated lactolycopene tablets, tomato paste or placebo (whey proteins) alongside their usual diets. They were asked to avoid lycopene-containing foods.
This study found that there was no difference in lycopene blood concentrations between those consuming the lycopene tablets and those taking tomato paste, though both were higher than those on the control diet.
It should be noted that the study did not look at the effects of lycopene on health. It merely investigated how “available” lycopene was to the body after ingestion in these different forms. There appeared to be no difference between the availability of 25mg of lycopene from a daily intake of 12.5g of lactolycopene powder or from 33g of tomato paste.
Is further research on Ateronon being performed?
The promotional website for Ateronon mentions other research but doesn’t provide details of the studies or information about whether this research has been published in peer-reviewed journals. It says that when given daily to older people with heart disease (mean age 61, range 40 to 70 years), Ateronon doubled the levels of lycopene in the blood in two weeks.
According to some news sources, a year-long trial in 200 people with heart disease will begin soon at Harvard University and a trial is also currently underway at Addenbrooke’s Hospital in Cambridge among haemorrhagic stroke patients.
Is Ateronon safe?
Overall, there is little evidence of the long-term health benefits or harms of the Ateronon pill in humans. Longer-term studies are needed to determine whether lactolycopene is effective and safe. The Ateronon tablet also contains milk and soya derivatives and will not be safe for people with allergies to these ingredients, or for those with tomato allergies.
If lycopene comes from tomatoes, can’t I just eat more tomatoes?
Ateronon has not been compared with raw tomatoes so it is not clear how much raw fruit would need to be consumed to obtain the same amount of lycopene as the pill provides. However, the research funded by Nestlé found that taking 12.5g of lactolycopene powder daily or eating 33g of tomato paste made similar amounts of lycopene available to the body
So what's the bottom line?
To date, no studies have assessed the long-term health effects of this pill. It is true that studies in humans have shown that the Mediterranean diet, or one supplemented with tomato products, has clinical benefits. However, it is not clear whether the lycopene in tomatoes is responsible for the benefits or whether this pill is more effective at delivering lycopene. Ultimately, only long-term clinical trials will be able to establish if Ateronon has long-term health benefits and whether these outweigh the benefits of a diet rich in tomatoes.
Importantly, studies in humans have yet to compare the pill with statin medications commonly prescribed to lower cholesterol. People should not attempt to replace their statins with these supplements without consulting their doctor.
Analysis by Bazian
Edited by NHS Website
Links to the headlines
Sun, 1 June 2009
Metro, 1 June 2009
Daily Express, 1 June 2009
Daily Telegraph, 1 June 2009