Lactagen was a nutritional supplement produced by Ritter Pharmaceuticals that claimed to reduce the symptoms of lactose intolerance. In 2011, Ritter Pharmaceuticals ceased sales of Lactagen, and other dietary supplements, in order to pursue FDA approval for a treatment for lactose intolerance. [1]
Symptoms said to be relieved by Lactagen include bloating, gas, diarrhea, and abdominal cramping which are associated with the symptoms of lactose intolerance. [2] Lactagen is a powder ingested with water or juice in increasing amounts for a period of 38 days. The manufacturer claims that the mixture of prebiotics and probiotics will relieve all symptoms permanently for eight out of ten users. Gastroenterologists suggest that Lactagen can relieve symptoms of lactose intolerance, but relief may not be permanent. [3]
Since Lactagen was a natural dietary supplement, it was not regulated by the U.S. Food and Drug Administration. Therefore, claims of effectiveness were not evaluated by the agency, and Ritter Pharmaceuticals can therefore not make any claims that Lactagen cures or prevents any disease. [3]
Founder and president of Ritter Pharmaceuticals, Andrew Ritter, suffered from severe lactose intolerance since his early childhood. [4] Medical experts told Ritter there was no treatment available and that he would have to manage suffering from lactose intolerance for the rest of his life. The condition dramatically affected his health and lifestyle, and thus he began a quest to develop a better solution for his condition. [5] In 1997, after years of suffering, Ritter used himself as the first test subject and developed a lactose intolerance treatment as a project for the California State Science Fair. [3]
Thereafter, Ritter assembled a team of leading lactose intolerance and gastrointestinal experts to formulate, develop and test an alternative solution for treating the condition. [6] In 2004, Ritter created Lactagen and began selling it commercially under the company name Ritter Pharmaceuticals, Inc. [7]
After identifying Lactagen, an early-generation product which demonstrated dramatic improvement in lactose intolerance symptoms, the team embarked on a formal FDA-approval clinical development process to establish efficacy and safety to ultimately be able to provide the treatment to the millions of lactose intolerance sufferers worldwide. [8]
The second generation product, called RP-G28, is a first-in-class compound with the potential to become the first FDA-approved drug for the treatment of lactose intolerance. [9] Ritter's pioneering scientific team developed this compound based on the philosophy of microbiome modulation and the ability to improve colon function by selectively increasing the growth of beneficial bacteria in the colonic ecosystem. [10]
Lactose intolerance (LI) is a widespread condition affecting over one billion people worldwide. [11] Approximately 40 million Americans (or 15% of the US population) suffer from lactose intolerance, with an estimated nine million of those individuals demonstrating moderate and severe symptoms. [12] Lactose intolerance is caused by a lack of the naturally produced enzyme lactase in the stomach. Lactose intolerance is exemplified by the inability to tolerate and fully digest dairy products, such as milk, ice cream, cheese and pizza. Symptoms may include a painful combination of digestive discomfort, including gas, cramping, bloating or diarrhea. [13] According to the American Academy of Pediatrics Committee on Nutrition (2006), "the symptoms of lactose intolerance can lead to significant discomfort, disruption of the quality of life, and loss of school attendance, leisure and sports activities, and work time, all at a cost to individuals, families, and society." [14]
Currently, there is no approved prescription treatment for LI. Most persons with LI avoid ingestion of milk and dairy products, while others substitute non-lactose-containing foods in their diet. However, complete avoidance of lactose-containing foods is difficult to achieve (especially for those with moderate to severe symptoms), and can lead to significant long-term morbidity, i.e., dietary deficiencies of calcium and vitamin D. [15]
At the 2010 National Institute of Health ("NIH") Consensus Development Conference: Lactose Intolerance and Health, the NIH highlighted numerous health risks tied to lactose intolerance, such as: osteoporosis; hypertension; and low bone density. [16] There is substantial evidence indicating that lactose intolerance is a major factor in limiting calcium and nutrient intake in the diet of people who are lactose intolerant. Adequate calcium intake is essential to reducing the risks of osteoporosis and hypertension. [17] In addition, chronic calcium depletion has been linked to increased arterial blood pressure, thereby establishing a relationship between hypertension and a low calcium intake. [18] Moreover, there is evidence of a correlation between calcium intake and both colon and breast cancer. [19]
Over 50% of lactose intolerant patients are very concerned that they may be susceptible to one of these health risks, as a result of their lactose intolerance. [20]
In a clinical study conducted by Ritter Pharmaceuticals medical board member [21] Chris Landon, M.D., Lactagen showed a statistically significant reduction in lactose intolerance symptoms. The results were gathered among sixty-subjects in a double-blind clinical trial at the Ventura County Medical Center in Los Angeles, California. Specifically, 79% of subjects on Lactagen reported a substantial reduction of lactose intolerant symptoms after completion of the 38-day program, while those on a placebo showed little or no reduction in symptoms. [22] The abstract from the study was published in FASEB Journal in 2006. [23]
At the National Institute of Health Consensus Development Conference on Lactose Intolerance and Health, experts stated that strategies such as colonic adaptation have intriguing preliminary data and may be useful for individuals with lactose intolerance, although additional research needs to be completed in the area. [24]
A study on colonic adaptation, published in the American Journal of Clinical Nutrition, concluded there is colonic adaptation to regular lactose ingestion. This related adaption reduces lactose intolerance symptoms. [25]
In an interview with the Washington Post, gastroenterologist Theodore Bayless of Johns Hopkins School of Medicine suggested that such a course can relieve symptoms of lactose intolerance, but the relief would not be permanent, particularly if the user were to take antibiotics at a later date. [3]
Dairy products or milk products, also known as lacticinia, are food products made from milk. The most common dairy animals are cow, water buffalo, nanny goat, and ewe. Dairy products include common grocery store food items in the Western world such as yogurt, cheese, milk and butter. A facility that produces dairy products is known as a dairy. Dairy products are consumed worldwide to varying degrees. Some people avoid some or all dairy products either because of lactose intolerance, veganism, or other health reasons or beliefs.
Lactose, or milk sugar, is a disaccharide sugar synthesized by galactose and glucose subunits and has the molecular formula C12H22O11. Lactose makes up around 2–8% of milk (by mass). The name comes from lac (gen. lactis), the Latin word for milk, plus the suffix -ose used to name sugars. The compound is a white, water-soluble, non-hygroscopic solid with a mildly sweet taste. It is used in the food industry.
Milk is a white liquid food produced by the mammary glands of mammals. It is the primary source of nutrition for young mammals before they are able to digest solid food. Immune factors and immune-modulating components in milk contribute to milk immunity. Early-lactation milk, which is called colostrum, contains antibodies that strengthen the immune system and thus reduce the risk of many diseases. Milk contains many nutrients, including protein and lactose.
Lactose intolerance is caused by a lessened ability or a complete inability to digest lactose, a sugar found in dairy products. Humans vary in the amount of lactose they can tolerate before symptoms develop. Symptoms may include abdominal pain, bloating, diarrhea, flatulence, and nausea. These symptoms typically start thirty minutes to two hours after eating or drinking something containing lactose, with the severity typically depending on the amount consumed. Lactose intolerance does not cause damage to the gastrointestinal tract.
Casein is a family of related phosphoproteins that are commonly found in mammalian milk, comprising about 80% of the proteins in cow's milk and between 20% and 60% of the proteins in human milk. Sheep and cow milk have a higher casein content than other types of milk with human milk having a particularly low casein content.
A dietary supplement is a manufactured product intended to supplement a person's diet by taking a pill, capsule, tablet, powder, or liquid. A supplement can provide nutrients either extracted from food sources, or that are synthetic. The classes of nutrient compounds in supplements include vitamins, minerals, fiber, fatty acids, and amino acids. Dietary supplements can also contain substances that have not been confirmed as being essential to life, and so are not nutrients per se, but are marketed as having a beneficial biological effect, such as plant pigments or polyphenols. Animals can also be a source of supplement ingredients, such as collagen from chickens or fish for example. These are also sold individually and in combination, and may be combined with nutrient ingredients. The European Commission has also established harmonized rules to help insure that food supplements are safe and appropriately labeled.
Whey is the liquid remaining after milk has been curdled and strained. It is a byproduct of the manufacturing of cheese or casein and has several commercial uses. Sweet whey is a byproduct resulting from the manufacture of rennet types of hard cheese, like cheddar or Swiss cheese. Acid whey is a byproduct brought out during the making of acid types of dairy products, such as strained yogurt.
Galactosemia is a rare genetic metabolic disorder that affects an individual's ability to metabolize the sugar galactose properly. Galactosemia follows an autosomal recessive mode of inheritance that confers a deficiency in an enzyme responsible for adequate galactose degradation.
Enterocytes, or intestinal absorptive cells, are simple columnar epithelial cells which line the inner surface of the small and large intestines. A glycocalyx surface coat contains digestive enzymes. Microvilli on the apical surface increase its surface area. This facilitates transport of numerous small molecules into the enterocyte from the intestinal lumen. These include broken down proteins, fats, and sugars, as well as water, electrolytes, vitamins, and bile salts. Enterocytes also have an endocrine role, secreting hormones such as leptin.
Malabsorption is a state arising from abnormality in absorption of food nutrients across the gastrointestinal (GI) tract. Impairment can be of single or multiple nutrients depending on the abnormality. This may lead to malnutrition and a variety of anaemias.
Vegetarian nutrition is the set of health-related challenges and advantages of vegetarian diets.
Food intolerance is a detrimental reaction, often delayed, to a food, beverage, food additive, or compound found in foods that produces symptoms in one or more body organs and systems, but generally refers to reactions other than food allergy. Food hypersensitivity is used to refer broadly to both food intolerances and food allergies.
A milk substitute is any substance that resembles milk and can be used in the same ways as milk. Such substances may be variously known as non-dairy beverage, nut milk, grain milk, legume milk, mock milk and alternative milk.
A low-residue diet is a diet intended to reduce certain constituents of the bowel, often with consequence for functional behaviour of the bowel. It may be prescribed for patients with ailments or functional gastrointestinal disorders mitigated by fewer and smaller bowel movements each day.
Abdominal distension occurs when substances, such as air (gas) or fluid, accumulate in the abdomen causing its expansion. It is typically a symptom of an underlying disease or dysfunction in the body, rather than an illness in its own right. People with this condition often describe it as "feeling bloated". Affected people often experience a sensation of fullness, abdominal pressure, and sometimes nausea, pain, or cramping. In the most extreme cases, upward pressure on the diaphragm and lungs can also cause shortness of breath. Through a variety of causes, bloating is most commonly due to buildup of gas in the stomach, small intestine, or colon. The pressure sensation is often relieved, or at least lessened, by belching or flatulence. Medications that settle gas in the stomach and intestines are also commonly used to treat the discomfort and lessen the abdominal distension.
Milk allergy is an adverse immune reaction to one or more proteins in cow's milk. Symptoms may take hours to days to manifest, with symptoms including atopic dermatitis, inflammation of the esophagus, enteropathy involving the small intestine and proctocolitis involving the rectum and colon. However, rapid anaphylaxis is possible, a potentially life-threatening condition that requires treatment with epinephrine, among other measures.
The DASH diet is a dietary pattern promoted by the U.S.-based National Heart, Lung, and Blood Institute to prevent and control hypertension. The DASH diet is rich in fruits, vegetables, whole grains, and low-fat dairy foods. It includes meat, fish, poultry, nuts, and beans, and is limited in sugar-sweetened foods and beverages, red meat, and added fats. In addition to its effect on blood pressure, it is designed to be a well-balanced approach to eating for the general public. DASH is recommended by the United States Department of Agriculture (USDA) as a healthy eating plan. The DASH diet is one of three healthy diets recommended in the 2015–2020 US Dietary Guidelines, which also include the Mediterranean diet and a vegetarian diet. The American Heart Association (AHA) considers the DASH diet "specific and well-documented across age, sex and ethnically diverse groups."
Sodium lactate is the sodium salt of lactic acid, and has a mild saline taste. It is produced by fermentation of a sugar source, such as corn or beets, and then, by neutralizing the resulting lactic acid to create a compound having the formula NaC3H5O3.
FODMAPs or fermentable oligosaccharides, disaccharides, monosaccharides, and polyols are short-chain carbohydrates that are poorly absorbed in the small intestine and ferment in the colon. They include short-chain oligosaccharide polymers of fructose (fructans) and galactooligosaccharides, disaccharides (lactose), monosaccharides (fructose), and sugar alcohols (polyols), such as sorbitol, mannitol, xylitol, and maltitol. Most FODMAPs are naturally present in food and the human diet, but the polyols may be added artificially in commercially prepared foods and beverages.
Virginia H. Holsinger was a food scientist whose research was significant in the dairy industry. Her research on enzymes as dietary supplements and food treatments was critical to the development of Lactaid and Beano.
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