Where are Sterols used

What is Cholesterol

Cholesterol is a waxy, fat-like substance that’s found in all cells of the body. Your body needs some cholesterol to make hormones, vitamin D, and substances to help digest foods. Your body makes all the cholesterol it needs. Cholesterol travels through your bloodstream in small packages called lipoproteins.
There are two kinds of lipoproteins: low-density lipoproteins (LDL) and high-density lipoproteins (HDL). Having healthy levels of both types of lipoproteins is important.
LDL cholesterol sometimes is called “bad” cholesterol. A high LDL level leads to a build up of cholesterol in your arteries which carry blood from your heart to your body.
HDL cholesterol sometimes is called “good” cholesterol. This is because it carries cholesterol from other parts of your body back to your liver. Your liver removes the cholesterol from your body.
Higher levels of LDL cholesterol increase the risk of heart disease. The arteries which carry blood become narrower as deposits of fat, calcium and other substances become solid lumps on the inside of the arteries, a condition known as “atherosclerosis”.
When the arteries which carry the blood to the heart to make it work become blocked then this can result in a “heart attack” which results in death in about 1 in 3 cases. Blockages of arteries taking blood to the brain can lead to strokes. Foods which contain higher amounts of Saturated Fat will increase the amount of LDL cholesterol in your body and when this is added to the natural amount of LDL cholesterol it can make the risk of heart disease and strokes even higher. Around 75% of your cholesterol is made by your liver. This can be reduced by taking Statins but is also reduced by Sterols. The remaining cholesterol is from your diet. This can be reduced by consuming less Saturated Fats or by consuming Cholesterol reducing foods containing Stanol or Sterols.

Sterols and Stanols

There are two cholesterol reducing ingredients based on plant sterols. The first is Sterols and the second is Stanols.
Stanols are sterols which have been further processed through hydrogenation. In recent years, hydrogenation has received bad publicity when related to the processing of vegetable oils. The hydrogenation process produces trans fatty acids in the oil and these are considered bad for heart health. The hydrogenation process for Stanols does not produce any trans fats and Stanols are good for reducing cholesterol and your heart.
Stanols are patented and almost exclusively sold by Raisio, a company based in Finland, the first to market products containing Sterols or their derivatives. The other main world-wide suppliers of products containing Sterols are Upfield with a range of spreads and yoghurts and Danone with their range of drinking yogurts.
Much research has been conducted to establish the efficacy of one over the other but at doses approved by health authorities (on-pack claims) there is little or no difference. Raisio have published research showing that at dose levels 3-4 times what is currently approved there is higher efficacy for Stanols. However, these claims have not been submitted for approval

How do Sterols and Stanols work

The molecular structure of Sterols and Stannols are very similar to cholesterol. When they travel through the intestine they partially block the absorbtion of cholesterol into the blood stream and the cholesterol that would have been absorbed is removed from the body by natural means and therefore there your cholesterol will be lower.

On-Pack Claims

Europe

Under EU regulation 1924/2006 an article 14 claim (disease and risk reduction) can be made that “Plant Sterols have been shown to lower/reduce blood cholesterol. Blood cholesterol lowering may reduce the risk of coronary heart disease” This applies to fat based foods and low fat foods such as yoghurt.
(http://www.efsa.europa.eu/en/scdocs/doc/781.pdf)

The EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) said in an opinion that cholesterol in the blood can be reduced on average by 7 to 10.5% if a person consumes 1.5 to 2.4 grams of plant sterols and stanols every day. They also concluded that foods such as yoghurts and milk, including low-fat yoghurts and cheese, margarine-type spreads, mayonnaise, salad dressing and other dairy products, were the most suitable for delivering the cholesterol-lowering effects from plant stanols and sterols to the body. For other foods, either information was lacking or they appeared to be less effective in reducing blood cholesterol levels.
Products containing Sterols and Stanols should only be consumed by people who need to control their blood cholesterol level.
Sterols
Under EU Regulation 258/97, Sterols are considered to be a “novel food” having not had a significant history of consumption prior to 15th May 1997. As such they require rigorous safety assessment and all new uses of Sterols must be approved by EFSA. Approval of Novel Foods only applies to products produced by the applying company, although it is possible to request an opinion on “equivalence” from an EU member state if your product is similar to, or the same as, the authorised product and you want to use your product in the same way as the authorised product.
Stanols
Raisio launched their first product in 1995 and as such Stanols are considered to have a significant history of consumption prior to 15th May 1997 and are therefore exempt from the Novel Food legislation and can be included in any new product.

North America

United States

Under FDA regulation 101.83 an on-pack claim can be made that “Foods containing at least 0.65 g per serving of plant sterol esters, eaten twice a day with meals for a daily total intake of at least 1.3 g, as part of a diet low in saturated fat and cholesterol, may reduce the risk of heart disease”. The claim for Stannols requires double the amount per serving, 1.3gm in order to make the same claim.
The composition of the Sterols or Stanols are also covered in the regulation and no claim can be made for the level of reduction of the risk for heart disease, nor any implication that consumption of food containing Sterols or Stanols are the only way to reduce the risk of Chronic Heart Disease. Furthermore it requires that the consumption of the necessary daily amounts should be taken over two meals. Products which can make these claims must also be able to satisfy FDA regulation 101.62 to be described as “low saturated fat” or “low cholesterol” and meet the nutrient levels set out in FDA regulation 101.14(4) Electronic code of federal regulations. Furthermore, products containing Sterols and Stanols should only be consumed by people who need to control their blood cholesterol level.

Canada

In May 2010, Health Canada’s Food Directorate approved the addition of plant sterols to a range of foods allowing packs to carry a statement of that a servings to provide a total daily amount of 2gm of sterols is “….shown to help reduce/lower cholesterol in adults.” In addition statements of “Plant sterols help reduce [or help lower] cholesterol” and “High cholesterol is a risk factor for heart disease” may also be added on the pack. Full details of of requirements are to be found at Plant Sterols and Blood Cholesterol Lowering and can be applied to spreads, mayonnaise, margarine, calorie-reduced margarine, salad dressing, yogurt and yogurt drinks, and vegetable and fruit juices.
No application for the approval of Stanols has been made in Canada.

Australia

Australia and New Zealand

On 18th January 2013 a law was passed to regulate claim and came into effect 3 years later, 18th January 2016. Under this new code the existing system of voluntary claims for those products which want to make a High Level Health Claim will need to be approved by FSANZ (Food Safety Australia and New Zealand). Under the initial regulation, Standard 1.2.7, Sterols and Stanols are one of the 13 foods permitted to make a High Level Health Claim. Foods must contain a minimum of 0.8gm per serving and enable a diet to contain of 2g per day.
Unlike Europe and North America, FSANZ do not specify what claim is to be made on the pack.

Corticosteroids are widely used to treat a number of conditions and are similar to Cortisol, a hormone produced in the adrenal glands. They are used to treat inflamed areas of the body. These areas can be internal as well as external so for example asthmatic problems as well as allergic reactions, arthritic conditions to skin Eczema.

Sterols are the starting material for this whole class of drugs and creams.

They are used to make 5 key starting materials shown in Green boxes, 4AD, Sitolactone, BA, 1,4-ADD and 9-OH-AD.

These materials in turn make a number of Intermediates (Yellow Boxes) and then into final drugs or creams (Blue Boxes).

The drugs and creams have a wide variety of applications from Estrogen & Progestin, the “female” hormones and are the basis of oral contraception or to reduce the symptoms of the menopause to Testosterone the “male” hormone and when taken is commonly referred to as an anabolic steroid (often considered an illegal drug) and is useful for increasing muscle mass and muscle strength. They are used to treat male hormone problems, the delayed on-set of puberty or muscle loss from some diseases such as cancer and AIDS.

A selected few others on the chart are – Hydrocortisone, normally applied as a topical cream to reduce skin inflammation in conditions such as Eczema. Prednisolone reduces the inflammation from the auto-immune condition rheumatoid arthritis. Dexamethsone can help reduce the side effects of cancer treatment.

With such a wide range of conditions being treated then steroid based products will continue to grow.

Cholesterol is a major contributor to the epidermal layer of the skin and provides elasticity (anti-wrinkling/ageing) and retention of moisture. Increasing cholesterol absorption into the epidermis from the inside of the body has the risks associated with having higher levels of cholesterol in the blood and the associated risk for Chronic Heart Disease while applying topically (externally) can cause acne and skin irritation. The application of a skin cream containing sterols is understood to mimic the application of cholesterol and therefore improve the quality of the epidermis.