20. SUPPLEMENTS Flashcards
THIS MODULE COVERS: • Supplements: Why use them, legislation, manufacturing, administration, cost excipients, dosages and absorption. • Natural v. synthetic supplements. • Different types and forms of nutritional supplements. • Mineral, vitamin and EFA supplements.
What is a food supplement defined as?
A concentrated source of a vitamin, mineral or other substance with a nutritional or physiological effect, alone, or in combination, sold in dose form.
Do herbal products have food supplement status?
Herbal products do not have food supplement status since they are classed as medicines.
Why use supplements?
- For deficiency states: Deficiency symptoms are end-stage symptoms associated with an extended lack of a particular vitamin, mineral or other nutrient.
- For therapeutic uses: Insufficiency can be identified when there is under-functioning of certain biochemical pathways, by nutritional evaluation, or by identification of other symptoms. Most disease starts and progresses due to an insufficiency of specific vitamins or minerals.
- For preventative health: Supplements are used to address any nutrient insufficiencies in order to maintain optimal health and wellness.
Name FIVE causative factors for supplements being needed.
- Food processing reduces nutrient content: best to eat whole organic food, locally sourced, in season and minimally processed.
-
Food additives deplete nutrients:
Many food additives are toxic, depleting the body of essential nutrients and impairing nutrient absorption. -
Weakened digestion:
Due to refined, low-quality food and medications. -
Stressful lifestyles:
Depletes nutrients including calcium, magnesium and zinc. -
Nutrient depletion at birth: Potential heavy
metal and chemical toxicity of the parents. - Soil is depleted: Zinc, manganese, chromium, molybdenum, calcium and magnesium.
- High-yield crops are deficient in certain nutrients: After years of intensive cultivation.
- Fertilisers: Do not supply enough trace minerals to plants.
- Pesticides deplete soil: Kill soil microorganisms needed to create nutrients for plants, thereby causing lower nutrient content.
- Long-distance transportation: Crops lose much of their nutritional value.
Where can we find what vitamin and mineral substances are permitted for use in food supplements?
The EU Food Supplements Directive gives a list of the vitamins and minerals, including the form in which they may be used, in the manufacture of food supplements.
It contains a legal requirement for the setting of maximum and minimum levels for vitamins and minerals in food supplements.
New sources of vitamins and minerals may be added to these lists if safety information is submitted and approved by the European Food Safety Authority (EFSA).
How are food supplements regulated in Ireland?
Ireland is regulated by EU legislation on food supplements.
The Food Safety Authority of Ireland (FSAI) oversees the implementation of all relevant legislation for food supplements.
How are food supplements regulated in the US?
All prescription and non-prescription drugs are regulated in the United States by the Food and Drug Administration (FDA).
In the US, dietary supplements are treated as a special category of food with different regulations to drugs. They are considered safe until proven otherwise.
Which organisation is responsible for licensing medicines in the UK?
The Medicines and Healthcare Products Regulatory Agency (MHRA).
Which organisation regulates medicinal products, medical devices and cosmetics?
The Health Products Regulatory Authority (HPRA).
Which organisation has the responsibility for national and EU legislation on food supplements in:
- England
- Wales
- Scotland and Northern Ireland?
- The Department of Health in England.
- The Welsh Assembly in Wales
- The local Food Standards Agencies in Scotland and Northern Ireland.
Compliance is monitored and enforced by local trading standards authorities but if pharmacologically-active substances or herbs are part of the product they will be sent to the MHRA for assessment.
How are herbal products regulated?
Many herbal ingredients are classified as medicines. Herbal products are regulated by the Traditional Herbal Medicines (THM) Directive, which is administered in the UK by the MHRA.
What claims are prohibited on food supplement labels?
- Medicinal claims.
- Presentation or labelling that infers that a supplement can prevent, treat or cure human disease.
- Reference to the rate or amount of weight loss.
- Reference to recommendations of individual doctors or health professionals.
- Health claims on alcoholic beverages.
- Claims which suggest that health could be affected by not consuming the food.
What checks are involved for animal-based supplements?
Any facility involved in the manufacture of animal-based supplements such as fish oils and glucosamine needs to be registered and approved by the European Commission.
Checks include where the animal was caught, farmed, handled, manufactured, extracted and packaged and the approval number must be displayed on the label.
Contaminants such as PCBs, dioxins and heavy metals must be within EU ‘acceptable levels’ for supplements.
Are genetically modified (GM) ingredients allowed in supplements?
Ingredients from GM organisms are only permitted for use in supplements if authorised under the Regulation on genetically modified food and feed.
This regulation requires companies to declare the presence of GM materials on food product and supplement labels.
The accidental presence of GM material may still occur in a non-GM crop via transference in nature; e.g. via windborne pollen.
Are companies required to be GMP-approved?
In the UK, supplement companies are required to manufacture with ‘due diligence’. There is a legal requirement that all products must be ‘fit for purpose’.
Many companies are GMP compliant (self-regulated) but not GMP approved. This means that supplements may be produced
to GMP standard with rigorous quality control, production and distribution procedures but without having actual GMP approval.
Few companies in the UK are GMP approved - most of these are Australian or American companies as they have to meet the standards set by the Therapeutics Goods Act (TGA) or Food and Drug Administration (FDA) in their respective countries.
What is GMP? What does it require?
Good manufacturing practice (GMP) is the minimum standard that a medicines’ manufacturer must meet in its production processes. Products must:
– Be of consistent high quality.
– Be appropriate to their intended use.
– Meet the requirements of the marketing authorisation (MA) or product specification.
TRUE or FALSE
The MHRA requires licensed medicines, herbal medicines and supplements to have GMP certification.
FALSE
The MHRA requires licensed medicines and herbal medicines to have GMP certification. As supplements are unlicensed they do not have to meet the requirements of GMP.
‘Whole food’ and ‘food form’ supplements are regulated as foods.
What tests are carried out by the regulatory agencies to check supplements?
High or unacceptable levels of heavy metals, solvent residue, aflatoxins, or herbicides and pesticides.
UK law limits contaminants such as arsenic; EU legislation limits amounts of materials such as mercury, lead and cadmium.
What is overage?
Ingredients may degrade over a supplement’s shelf life. Reputable supplement companies will add extra so that the amount left at the end of its shelf life still meets the label claim. This is called overage.
How could the way that certain ingredients are processed, affect their quality?
eg. fish oil, whey protein
Fish oil and omega plant oils need to be cold-pressed to minimise oxidation; whey protein needs to be specially filtered to remove lactose, hormones, etc.
Cheaper extraction and processing methods reduce the effectiveness of the supplement and affects its safety profile.
What are the considerations when choosing between tablets to capsules in terms of supplementation.
Tablets: Cheaper, easier to produce large quantities. Generally contain more excipients so try to avoid.
Capsules: Fewer excipients but not efficient for large doses.
Compare powders to liquids as forms of supplementation.
Powders: Good for bigger doses; e.g. glutamine. Not suitable for sticky ingredients, ones that attract moisture, e.g. phosphatidyl serine or fruit powders, where there is a toxicity risk, or where ingredients are unstable.
Liquids: Excellent absorption but more expensive and less stable. Many, such as fish oils, need antioxidants such as vitamin E added to prevent oxidation.
What are the advantages of enteric formulations?
Excipients, such as shellac or cellulose acetate phthalate (CAP) ensure tablets survive stomach acid so that they don’t release contents until the small intestine. Commonly used for good garlic capsules.
Name a good form of supplements to enable probiotics to survive the stomach acid and reactivate in the intestines.
Spore form
Why do we need chewable formulations of supplements?
As vitamins and minerals may taste unpleasant, most vitamin and mineral powders are coated before they are compressed into tablets.
Cheaper slow-release tablets contain ______________ to hold the tablets together longer.
hydrogenated fats
What are liposomal supplements and their advantages?
Liposomal supplements have a protective phospholipid bilayer protecting the active ingredients.
- High bioavailability and absorption.
- Increased oral uptake in the mouth.
- Increased uptake into target cells.
- Easier to take than large tablets.
- Suitable for water- and fat-soluble nutrients.
What are excipients and why are they used in a supplement?
Excipients are additives used in forming tablets and capsules to bind active ingredients together and keep them active (potentially harmful).
Give FIVE examples of excipients in supplements.
- Capsule shells: Made from gelatine or from plant cellulose.
- Flow agents: Help formulations flow easily through machinery but no nutritional benefit. Avoid magnesium stearate.
- Binding agents: Help to bind ingredients together to make a tablet; e.g. maltodextrin.
- Fillers. Help to fill capsules, particularly when small amounts of an active nutrient is needed e.g. B12 or vitamin D.
- Natural fillers: lithothamnion calcareum from fossilised seaweed; vegetable powder; new form of rice flour that is inert.
- Emulsifiers. Used to mix oily and watery ingredients together.
- Flavours. Avoid MSG.
- Colours: riboflavin, beet extract, turmeric.
- Sweeteners: glycerine.
- Preservatives: vitamin E, ascorbic acid.
What does the naturopathic approach to supplementing involve?
- Addressing the underlying cause of any dysfunction and treating the whole person, rather than the disease.
- It is vital that supplements are taken underthe best conditions to achieve maximum absorption, assimilation and utilisation.
- A naturopathic nutritionist understands that everyone is unique and that many factors must be considered to ensure that appropriate supplements are used in the correct dosage for optimal efficacy.
Where does absorption occur?
Absorption mostly occurs in the duodenum and jejunum but chemical bonds are broken in the stomach.
Give THREE examples of the nutrients absorbed in the duodenum and jejunum. What nutrient is absorbed in the ileum?
Duodenum: Calcium, selenium, magnesium, chromium, iron, manganese, zinc.
Jejunum: B vitamins, biotin, vitamin C, choline, inositol, calcium, magnesium.
Ileum: Vitamin B12.
B vitamins and vitamin C
Best way to take water-soluble vitamins.
When is it best to avoid taking B vitamins and why?
Most B vitamins and vitamin C: Take with food.
B vitamins: Contraindicated in the evening as they may trigger or exacerbate insomnia (B6 is the exception).
Best way to take fat-soluble nutrients.
Vitamins A, D, E, K and CoQ10: Take with food containing fat.
Essential fatty acids: Take with food. It is preferable not to take with high amounts of their opposing fat; if taking omega-3 then
avoid high amounts of omega-6 in the same meal.
Best way to take amino acids
- Ideally with carbohydrate food / drink or on an empty stomach.
- Protein shakes: take any time of day. Often used post-surgery or after extreme exercise to restore energy and rebuild muscle.
Protein shakes take about 30 minutes to reach the muscle after ingestion so are quicker to digest than solid food.
Absorption of amino acids in liquid shakes depends on transit time through gut, stomach acid, proteolytic enzymes, etc.
What is the best way to take minerals and what is their digestion dependent on? What time would you recommend taking Ca, Mg and Zn?
Minerals are best taken with food. Adequate stomach acid is needed for their digestion.
- Calcium and magnesium: Take in the evening to aid restful sleep.
- Zinc: Take on an empty stomach before bed. Caution: Some people may suffer stomach discomfort after taking zinc.
What should we consider to work out the dosage for a client?
- Age of the client: May need a higher dose with increasing age.
- Digestive capability: Ability to absorb and excrete? Constipated?
- State of health: Dosing for optimum health or for disease state?
- Therapeutic doses: Evidence of dosages that are shown in clinical trials to be effective for certain disease states.
- Dietary deficiency or insufficiency: What symptoms are there?
- Lab test results: What do these indicate?
- Safe therapeutic range: Age group of client?
What is an ‘elemental mineral’ in a supplement?
Labels in the UK / IRL state the elemental amount of minerals - the amount of mineral available for absorption when it has been freed from its carrier molecule.
The ‘elemental mineral’ is the amount of the mineral that is actually used by the body.
What is a natural supplement?
The term ‘natural’ can be used even if only 10% of the product is natural. The other 90% could be synthetic.
Depending on the manufacturing process, natural supplements may actually contain synthetic nutrients added to a food paste and grown into a more nutritious food matrix.
Some methods involve synthetic nutrients being biochemically incorporated into yeast or algae.
Why is it better to choose the vitamins from whole foods over manufactured synthetic isolates?
The body recognises when nutrients are derived from food and includes the necessary co-factors. It may not recognise isolates.
Natural supplements usually have better bowel tolerance than synthetic ones so they are retained longer in the body.
Give an example of a supplement from a natural source.
Nutrients from vegetable, animal or mineral sources.
- Vitamin D from fish liver oils,
- vitamin E from vegetable oils,
- natural betacarotene.
- Vitamin K.
Give an example of a supplement from a synthetic source.
Manufactured with identical molecular structure to the same natural nutrients. Most standard vitamin supplements are this type. Sometimes used preferentially by practitioners when trying to use higher doses.
Vitamin C: As this is a weak acid, many supplements use salt forms (calcium ascorbate, magnesium ascorbate) to decrease acidity.
Give an example of a supplement from a food cultured source. How are they made?
Whole food multivitamins, minerals and other nutrients.
It is thought culturing makes nutrients that are more bioavailable. Nutrient supplements are often grown in yeast or algae and contain the nutrients they are fed in a whole food complex form.
This involves the same process behind cultured foods like yoghurt, kefir, miso, and sauerkraut.
What is hydroponics?
Growing of plants in nutrient solutions with or without an inert medium (such as soil).
What is a supplement from a food based source?
This is a physical mix of isolated nutrients within a food base but there may not always be bonding at a cellular level. However, the metabolic outcome may be the same as food-cultured as the body recognises these two forms as food.
Made by enzymatically reacting synthetic and natural vitamins with extracts containing vegetable proteins and then making this into a supplement. This is not food cultured, because the nutrients are not grown into a whole food, as in yeast / algae suspensions.
Give an example of when a synthetic form of a supplement can be more useful or / and a natural form cannot be used.
If you use ascorbic acid, the most common synthetic form of vitamin C, it will be rapidly excreted from the body but will take a significant amount of free radicals with it. This is ideal if detoxification is the desired outcome.
Vitamin B9 - labelling laws insist that companies use folic acid or methylfolate as the product descriptor. Food state folate is not the same as traditional folic acid. It’s not methylfolate either as this does not occur in plants. Methylation only takes place in the human body or in a laboratory process - hence methylfolate, although the most bio-effective form of folate, cannot be natural or from food sources.
Name TWO reasons why synthetic supplements may be preferential to food-state.
Food-state supplements may not be enough to supply the optimal dosage when someone has a high nutritional requirement due to:
- poor dietary habits and lifestyle
- environmental factors
- chronic health conditions.
Sensitivities to foods or fillers in food-based products, such as gluten or nightshades can cause mild to severe reactions. Isolated, synthetic nutrient products may work better for some sensitive people.
What is a naturopathic approach to supplementation?
Naturopaths embrace a philosophy of using formulations that have a scientific, but holistic approach to supplementation.
- favour the use of whole, unadulterated botanicals and phytonutrient-rich foods optimally combined with vitamins, minerals, enzymes, coenzymes and amino acids.
- try to avoid preservatives, colourants, fillers or binding agents to allow the activity of, and synergy between, vitamins, minerals, plant enzymes, phytonutrients without physiological or biochemical interference.
- avoid GMO and irradiated products.
