Lactagen

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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]

Contents

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]

History

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

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]

Clinical data

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]

Effectiveness

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]

Related Research Articles

<span class="mw-page-title-main">Dairy product</span> Food product made from milk

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 around the world such as yogurt, cheese, milk and butter. A facility that produces dairy products is a dairy. Dairy products are consumed worldwide to varying degrees. Some people avoid some or all dairy products because of lactose intolerance, veganism, environmental concerns, other health reasons or beliefs.

<span class="mw-page-title-main">Lactose</span> Carbohydrate

Lactose, or milk sugar, is a disaccharide composed of galactose and glucose and has the molecular formula C12H22O11. Lactose makes up around 2–8% of milk (by mass). The name comes from lact (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.

<span class="mw-page-title-main">Lactase</span> Milk-sugar digesting enzyme

Lactase is an enzyme produced by many organisms and is essential to the complete digestion of whole milk. It breaks down the sugar lactose into its component parts, galactose and glucose. Lactase is found in the brush border of the small intestine of humans and other mammals. People deficient in lactase or lacking functional lactase may experience the symptoms of lactose intolerance after consuming milk products. Microbial β-galactosidase can be purchased as a food supplement and is added to milk to produce "lactose-free" milk products.

<span class="mw-page-title-main">Lactose intolerance</span> Inability to digest 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.

<span class="mw-page-title-main">Casein</span> Family of proteins found in milk

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.

<span class="mw-page-title-main">Galactosemia</span> Medical condition

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.

<span class="mw-page-title-main">Rice milk</span> Plant milk made from rice

Rice milk is a plant milk made from rice. Commercial rice milk is typically manufactured using brown rice and brown rice syrup, and may be sweetened using sugar or sugar substitutes, and flavored by common ingredients, such as vanilla. It is commonly fortified with protein and micronutrients, such as vitamin B12, calcium, iron, or vitamin D.

<span class="mw-page-title-main">Enterocyte</span> Type of intestinal cell

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.

<span class="mw-page-title-main">Malabsorption</span> Abnormality in absorption of food nutrients across the gastrointestinal tract

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.

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.

Lactase persistence or lactose tolerance is the continued activity of the lactase enzyme in adulthood, allowing the digestion of lactose in milk. In most mammals, the activity of the enzyme is dramatically reduced after weaning. In some human populations though, lactase persistence has recently evolved as an adaptation to the consumption of nonhuman milk and dairy products beyond infancy. Lactase persistence is very high among northern Europeans, especially Irish people. Worldwide, most people are lactase non-persistent, and are affected by varying degrees of lactose intolerance as adults. However, lactase persistence and lactose intolerance can overlap.

<span class="mw-page-title-main">Milk substitute</span> Alternative substance that resembles milk

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.

<span class="mw-page-title-main">Abdominal distension</span> Physical symptom

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.

<span class="mw-page-title-main">Milk allergy</span> Type of food allergy caused by milk

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 Dietary Approaches to Stop Hypertension or the DASH diet is a diet to control hypertension promoted by the U.S.-based National Heart, Lung, and Blood Institute, part of the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services. 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 2015–20 U.S. 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."

<span class="mw-page-title-main">Sodium lactate</span> Chemical compound

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 maize 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.

<span class="mw-page-title-main">Calcium supplement</span> Dietary mineral supplement

Calcium supplements are salts of calcium used in a number of conditions. Supplementation is generally only required when there is not enough calcium in the diet. By mouth they are used to treat and prevent low blood calcium, osteoporosis, and rickets. By injection into a vein they are used for low blood calcium that is resulting in muscle spasms and for high blood potassium or magnesium toxicity.

<span class="mw-page-title-main">Virginia Holsinger</span> American food scientist

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.

References

  1. ↑ "Ritter Pharmaceuticals". Archived from the original on 2018-08-18. Retrieved 2011-10-10.
  2. ↑ Schaeffer, Juliann. "Ice Cream for All? Lactagen and Lactose Intolerance." Today's Dietician Apr. 2008: 24-26.
  3. 1 2 3 4 Huget, Jennifer (29 November 2005). "Out of Gas?". Claim Check. Washington Post. Retrieved 3 August 2009.
  4. ↑ Gott, Dr. Peter (September 16, 2007). "Lactagen Helps Reader Enjoy Milk Again". No. Sunday Edition. The Courier News: A Division of the Chicago Tribune.
  5. ↑ Gott, Dr. Peter (September 16, 2007). "Lactagen Helps Reader Enjoy Milk Again". No. Sunday Edition. The Courier News: A Division of the Chicago Tribune.
  6. ↑ Khan, Mickey Alam (21 July 2004). "Lactagen hopes search test does a body good". Search Marketing. DMNews.com. Archived from the original on 29 February 2012. Retrieved 10 August 2009.
  7. ↑ "Leadership". Ritter Pharmaceuticals. Archived from the original on April 19, 2014. Retrieved October 10, 2011.
  8. ↑ "About Us". Ritter Pharmaceuticals. Archived from the original on April 19, 2014. Retrieved October 10, 2011.
  9. ↑ Gott, Dr. Peter (September 16, 2007). "Lactagen Helps Reader Enjoy Milk Again". No. Sunday Edition. The Courier News: A Division of the Chicago Tribune.
  10. ↑ Gott, Dr. Peter (September 16, 2007). "Lactagen Helps Reader Enjoy Milk Again". No. Sunday Edition. The Courier News: A Division of the Chicago Tribune.
  11. ↑ "Lactose Intolerance and Health" (PDF). NIH Consensus and Development Statement. 27 (2). February 22, 2010.
  12. ↑ "Lactose Intolerance". National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Retrieved 19 December 2006.
  13. ↑ Bowen, R. (28 December 2006). "Lactose Intolerance (Lactase Non-Persistence)". Pathophysiology of the Digestive System. Colorado State University. Archived from the original on 2010-06-23. Retrieved 2010-03-07.
  14. ↑ Heyman, Melvin (September 2006). "Lactose Intolerance in Infants, Children, and Adolescents". Pediatrics. 118 (3): 1284. doi:10.1542/peds.2006-1721. PMID   16951027. S2CID   2996092.
  15. ↑ Such, Brannon, Varpenter, F., P., T.; et al. (2010). "Lactose Intolerance and Health". NIH Consensus Development Conference Statement.{{cite journal}}: CS1 maint: multiple names: authors list (link)
  16. ↑ Such, F.; et al. (2010). "Lactose Intolerance and Health". NIH Consensus Development Conference Statement: 1–27.
  17. ↑ McCarron and Heaney. "Steps to a Healthier You: Dairy's Role in a Healthier Lifestyle" (PDF). nationaldairycouncil.org. US Department of Agriculture. Archived from the original (PDF) on 2014-12-22. Retrieved 19 December 2015.
  18. ↑ Karanja, N.; et al. (1987). "Plasma Lipids and Hypertension: Response to Calcium Supplementation". American Journal of Clinical Nutrition. 45 (1): 60–65. doi:10.1093/ajcn/45.1.60. PMID   3799505.
  19. ↑ Barger-Lux and Heaney (August 1, 1994). "The role of calcium intake in preventing bone fragility, hypertension and certain cancers". The Journal of Nutrition. 124 (8 Supplement): 1406S –1411S. doi: 10.1093/jn/124.suppl_8.1406S . PMID   8064393.
  20. ↑ Objective Insights (June 2012). Market Research Analysis and Forecasts on Lactose Intolerance and RP-G28.
  21. ↑ "Ritter Pharmaceuticals Medical Board". Ritter Pharmaceuticals, Inc. 2008. Archived from the original on 31 December 2011. Retrieved 10 August 2009.
  22. ↑ "Lactagen Launches Breakthrough One-Time Treatment for Lactose Intolerance; Clinical Study Proves Lactagen's Revolutionary 38-Day Program Allows Sufferers to Reintroduce Dairy into Diet". Business Wire. bnet. 14 November 2005. Archived from the original on 1 May 2009. Retrieved 10 August 2009.
  23. ↑ Landon, Chris, Tracy Tran, David Connell, Federation of American Societies for Experiment Biology Journal, 20, No 5., 2006
  24. ↑ "National Institute of Health Consensus Development Statement; NIH Consensus Development Conference: Lactose Intolerance and Health" (PDF). Retrieved 24 February 2010.
  25. ↑ Colonic adaptation to daily lactose feeding in lactose maldigesters reduces lactose intolerance, American Journal of Clinical Nutrition Vol 64, 232-236. The American Society for Clinical Nutrition, Inc 1996
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