Formulating Nutritional Products to Address Migraine

Headaches are a common occurrence. Whether it develops from stress, a common illness such as the flu, or overindulgence from a night out with friends, headaches can range from dull ache to debilitating pain. While they can usually be treated with aspirin, ibuprofen or acetaminophen, a certain type of headache—migraine—can be incapacitating.

Migraine headaches affect about 15 percent of the population, with three times as many women as men experiencing them. More than 80 percent of migraineurs (those people suffering from migraines) have family members who have migraines as well.

The different types of migraine can be differentiated by the presence or absence of an aura, such as perception of unpleasant smells or a visual disturbance such as tunnel vision or flashing lights. Common migraines, which account for 80 percent of migraine headaches, have no aura before onset; classic migraines are preceded by an aura and are usually much worse than common migraine. Status migrainosus is a long-lasting migraine that does not go away by itself.

There are several known triggers for a migraine, some of which include food allergies (especially due to chocolate, cheese, nuts and alcohol), blood sugar disturbances, stress load, mechanical injury and hormonal fluctuations. A migraine headache typically lasts from four to 72 hours. It usually affects only one side of the head, although they can affect both sides, and occur with nausea, vomiting and extreme sensitivity to light or sound. The headache pain is often described as throbbing or piercing and may range from mild to very severe.

Migraine headaches most frequently occur in early morning hours. Approximately 60 percent of migraineurs also suffer from prodromal symptoms, which may last for hours or days prior to the onset of the headache. These symptoms can vary widely, yet are usually consistent in an individual. They may manifest with psychological indicators such as irritability, anxiety, depression, fatigue, drowsiness or euphoria; neurologic symptoms such as photophobia (aversion to light), phonophobia (fear or sensitivity to loud sounds or voices) or hyperosmia (increased sense of smell); constitutional symptoms such as diarrhea, constipation, polyuria or stiff neck; or autonomic symptoms such as thirst, yawning or food cravings. Auras are experienced by 10 to 15 percent of migraineurs and generally last 10 to 30 minutes prior to the development of a headache.

Traditionally, migraine headaches have been treated with either over-the-counter (OTC) medications or, in the most severe cases, prescription medications. While these methods have certainly proved their value, a growing number of consumers are looking for a more holistic, dietary-centered approach to managing this malady. This is where nutritional supplementation and fortification can play a vital role.

Nutritional Solutions

Magnesium’s role in the pathogenesis of migraine headaches has been clearly established in numerous clinical and experimental studies. However, the precise role of how and why low levels of magnesium increase the risk of migraines remains to be discovered. It may possibly be due to how magnesium levels affect serotonin receptors, the synthesis and release of nitric oxide (NO), NMDA receptors and numerous other migraine-related receptors and neurotransmitters. Infusion of magnesium often results in rapid and sustained relief in many individuals. An enhanced water product would be an ideal delivery vehicle for this nutrient.

Another important mineral is calcium, particularly in combination with vitamin D. Two case studies report a combination of vitamin D and calcium was effective in reducing the frequency and duration of migraine attacks. The first study involved two postmenopausal women who developed frequent and excruciating migraine headaches (one following estrogen replacement therapy and the other following a stroke). Therapeutic supplementation of calcium and vitamin D resulted in a dramatic reduction in the frequency and duration of their migraine headaches.

The second study examined two premenopausal women with a history of premenstrual syndrome (PMS) coupled with menstrual-related migraines. Each woman was treated with a combination of vitamin D and elemental calcium for late luteal phase symptoms of PMS. Within two months of therapy, both women experienced fewer migraines and PMS symptoms. The results of these two small case studies suggest vitamin D and calcium therapy should receive consideration as a possible treatment of migraine headaches. Dairy products would be an obvious choice for a delivery vehicle, but non-citrus juices and bars could also be considered.

Another important vitamin is riboflavin (B2). High-dose riboflavin therapy has proven to be remarkably effective in the treatment of migraine headaches. In an open study, 55 patients took 400 mg/d of vitamin B2 for three months. Riboflavin was far superior to placebo in reducing the frequency of migraine attacks and the number of days with headache. The number of patients who improved by at least 50 percent (responders) was 59 percent for riboflavin compared to 15 percent for the placebo patients. The results of this study suggest high-dose riboflavin could thus be an effective, low-cost prophylactic treatment of migraines with no significant side effects.

Fortifying various food and beverage applications with select herbs can also aid in helping to reduce or lessen the pain associated with migraine headaches. For example, feverfew has gained immense popularity because of its effectiveness in reducing the severity, duration and frequency of migraine headaches. Including it in a daily diet for a minimum of one month is recommended for the prevention of migraines, but clinical studies have shown very little effect on active migraines.

In Ayurvedic medicine, turmeric rhizome has been used for centuries internally as a tonic for the stomach and liver and as a blood purifier, and externally in the treatment and prevention of skin diseases and in arthritic complaints. Curcumin, its main active ingredient, offers antioxidant as well as anti-inflammatory properties. It has a similar action to that of aspirin and aspirin-like anti-inflammatory agents.

Decreasing and managing stress may also play a key role in relieving and preventing migraine headaches. The herb kava has been used for centuries by South Pacific natives. In European phytomedicine, kava has long been used as a safe, effective treatment for mild anxiety states, nervous tension, muscular tension and mild insomnia. It is thought that kava may promote relaxation, sleep and rest by altering the way in which the limbic system modulates emotional processes.

Additional specialty compounds include evening primrose oil (EPO) and 5-HTP (5 hydroxy-tryptophan). EPO is rich in gamma-linolenic acid (GLA), an omega-6 essential fatty acid (EFA) that may inhibit inflammation. 5-HTP is produced by the body during its generation of serotonin, leading researchers to postulate supplemental 5-HTP could increase levels of serotonin. This hormone may be involved in migraine onset and antidepressants that raise serotonin levels sometimes seem to help prevent migraines; 5-HTP may provide similar benefits.

Formulation Considerations

As manufacturers push the envelope in applying nutrients to food and beverage compositions that have no natural precedent for these ingredients, formulators must take special care to anticipate and circumvent potential damage to nutrient integrity. The manner of addition, essentially the market form and timing of integration of a nutrient or nutrients, can have great impact on stability.

Ideally, the chemical form and timing of integration should provide uniformity of distribution and maximum stability in the product. Choice should include consideration of factors such as chemical and physical properties of the nutrients, the nature of the food environment (e.g. dry or moist) and how the product is to be handled following addition. The choice of the chemical form of the nutrient is critical. Certain salts or esters are more stable than others. It may be necessary in some systems to add the nutrient in a protective carrier or coating in order to prevent destruction or losses during processing or storage. Of course, such protective mechanisms must not interfere with the availability of the nutrient upon ingestion. It is important that the consideration of specific market forms be specific to each given premix or specific application, since data cannot be extrapolated from one system to another.

Timing of addition is also significant, since it is best to subject some nutrients to the least amount of heat or the least exposure to air. For example, certain nutrients that are known to degrade under heat (vitamin C, D, thiamine) may be sprayed onto the finished product rather than integrated during processing. Or nutrients that quickly degrade in moist or wet environments (vitamin B12, thiamine, pantothenic acid) may be prepared to be added as mix-ins to a liquid substrate just before consumption.

There are specific issues in certain processing systems. Thermal processing has to be optimized in order to obtain its desirable values, yet minimize nutrient losses by leaching or destructive reactions. Some of the most significant losses of vitamins and minerals occur during washing and cooking of food products. Water-soluble vitamins and certain trace minerals will be lost during this process. If possible, any additions of fortifying nutrients would be made after these steps. Most difficult to deal with are the destructive effects of retort sterilization. Vitamin B1, pantothenic acid and several other vitamins are quite heat labile. Substantial overages have conventionally been utilized to compensate for these losses, although coated market forms may provide an alternate to some overages. Lysine, threonine and other sulfur amino acids are particularly reactive to heat as are proteins containing these amino acids. If reducing sugars are present or if they are formed during processing, proteins may be degraded by the Maillard or other reactions.

Many of the above mentioned reactions also occur during drying or baking and, in some cases, at a more rapid rate. Careful control of drying conditions, use of antioxidants and encapsulation methods of addition can be helpful, but if possible, any additions of heat labile nutrients should be made after drying has been accomplished.

Losses of nutrients can also occur during storage, shipping and sale; but, generally these losses are minimal and can be avoided. Particular attention must be focused on time/temperature relationships and protection from light and oxygen. Proper packaging and inventory controls are effective means of avoiding problems.

Developing nutritional products to aid consumers suffering from migraine headaches provides manufacturers with new opportunities for growth. Incorporating appropriate nutrients to address this debilitating condition, along with others that contribute to their overall health and wellness will greatly influence their purchasing decisions. To successfully introduce new products to the marketplace, a manufacturer needs to lay a solid foundation at the very beginning of the development process. That foundation should include partnering with an experienced formulator to minimize the challenges associated with not just bringing their products to market, but to ensure a product that lives up to its label claims delivers repeat purchase.

Ram Chaudhari, Ph.D., FACN, CNS, is the senior executive vice president and chief scientific officer at Fortitech Inc. For more information on nutrient premixes and formulation, visit Fortitech.com.