Lactitol is a

sugar alcohol Sugar alcohols (also called polyhydric alcohols, polyalcohols, alditols or glycitols) are organic compounds, typically derived from sugars, containing one hydroxyl group (–OH) attached to each carbon atom. They are white, water-soluble solids ...

used as a replacement bulk

sweetener {{Wiktionary, sweetener A sweetener is a substance added to food or drink to impart the flavor of sweetness, either because it contains a type of sugar, or because it contains a sweet-tasting sugar substitute. Many artificial sweeteners have been ...

for low

calorie The calorie is a unit of energy. For historical reasons, two main definitions of "calorie" are in wide use. The large calorie, food calorie, or kilogram calorie was originally defined as the amount of heat needed to raise the temperature of on ...

foods Food is any substance consumed by an organism for nutritional support. Food is usually of plant, animal, or fungal origin, and contains essential nutrients, such as carbohydrates, fats, proteins, vitamins, or minerals. The substance is ingest ...

with 30–40% of the sweetness of

sucrose Sucrose, a disaccharide, is a sugar composed of glucose and fructose subunits. It is produced naturally in plants and is the main constituent of white sugar. It has the molecular formula . For human consumption, sucrose is extracted and refined ...

. It is also used medically as a

laxative Laxatives, purgatives, or aperients are substances that loosen stools and increase bowel movements. They are used to treat and prevent constipation. Laxatives vary as to how they work and the side effects they may have. Certain stimulant, lubri ...

. Lactitol is produced by two manufacturers,

Danisco Danisco A/S is a Danish bio-based company with activities in food production, enzymes and other bioproducts as well as a wide variety of pharmaceutical grade excipients. It was formed in 1989 from the largest Danish industrial merger ever of th ...

and Purac Biochem.

Applications

Lactitol is used in a variety of low

food energy Food energy is chemical energy that animals (including humans) derive from their food to sustain their metabolism, including their muscle, muscular activity. Most animals derive most of their energy from aerobic respiration, namely combining the ...

low fat Diet food (or dietetic food) refers to any food or beverage whose recipe is altered to reduce fat, carbohydrates, and/or sugar in order to make it part of a weight loss program or diet. Such foods are usually intended to assist in weight loss or ...

foods. High stability makes it popular for

baking Baking is a method of preparing food that uses dry heat, typically in an oven, but can also be done in hot ashes, or on hot stones. The most common baked item is bread but many other types of foods can be baked. Heat is gradually transferred " ...

. It is used in sugar-free candies, cookies (biscuits),

chocolate Chocolate is a food made from roasted and ground cacao seed kernels that is available as a liquid, solid, or paste, either on its own or as a flavoring agent in other foods. Cacao has been consumed in some form since at least the Olmec civ ...

, and

ice cream Ice cream is a sweetened frozen food typically eaten as a snack or dessert. It may be made from milk or cream and is flavoured with a sweetener, either sugar or an alternative, and a spice, such as cocoa or vanilla, or with fruit such as str ...

, with a sweetness of 30–40% that of sucrose. Lactitol also promotes colon health as a prebiotic. Because of poor absorption, lactitol only has 2–2.5

kilocalorie The calorie is a unit of energy. For historical reasons, two main definitions of "calorie" are in wide use. The large calorie, food calorie, or kilogram calorie was originally defined as the amount of heat needed to raise the temperature of on ...

s (8.4–10.5

kilojoule The joule ( , ; symbol: J) is the unit of energy in the International System of Units (SI). It is equal to the amount of work done when a force of 1 newton displaces a mass through a distance of 1 metre in the direction of the force applied. ...

s) per

gram The gram (originally gramme; SI unit symbol g) is a Physical unit, unit of mass in the International System of Units (SI) equal to one one thousandth of a kilogram. Originally defined as of 1795 as "the absolute weight of a volume of pure wate ...

, compared to 4 kilocalories (17 kJ) per gram for typical

saccharide In organic chemistry, a carbohydrate () is a biomolecule consisting of carbon (C), hydrogen (H) and oxygen (O) atoms, usually with a hydrogen–oxygen atom ratio of 2:1 (as in water) and thus with the empirical formula (where ''m'' may or may ...

s. Hence, lactitol is about 60% as caloric as typical saccharides.

Medical

Lactitol is listed as an

excipient An excipient is a substance formulated alongside the active ingredient of a medication, included for the purpose of long-term stabilization, bulking up solid formulations that contain potent active ingredients in small amounts (thus often referred ...

in some prescription drugs. Lactitol is a laxative and is used to prevent or treat

constipation Constipation is a bowel dysfunction that makes bowel movements infrequent or hard to pass. The stool is often hard and dry. Other symptoms may include abdominal pain, bloating, and feeling as if one has not completely passed the bowel movement ...

, e.g., under the trade name Importal. In February 2020, Lactitol was approved for use in the United States as an osmotic laxative for the treatment of

chronic idiopathic constipation Functional constipation, known as chronic idiopathic constipation (CIC), is constipation that does not have a physical (anatomical) or physiological (hormonal or other body chemistry) cause. It may have a neurological, psychological or psychoso ...

(CIC) in adults. Lactitol in combination with

Ispaghula Psyllium , or ispaghula , is the common name used for several members of the plant genus ''Plantago'' whose seeds are used commercially for the production of mucilage. Psyllium is mainly used as a dietary fiber to relieve symptoms of both constip ...

husk is an approved combination for

idiopathic An idiopathic disease is any disease with an unknown cause or mechanism of apparent wikt:spontaneous, spontaneous origin. From Ancient Greek, Greek ἴδιος ''idios'' "one's own" and πάθος ''pathos'' "suffering", ''idiopathy'' means approxi ...

constipation as a laxative and is used to prevent or treat constipation.

Safety and health

Lactitol,

erythritol Erythritol is an organic compound, a four-carbon sugar alcohol (or polyol) with no optical activity, used as a food additive and sugar substitute. It is naturally occurring. It can be made from corn using enzymes and fermentation. Its formula i ...

sorbitol Sorbitol (), less commonly known as glucitol (), is a sugar alcohol with a sweet taste which the human body metabolizes slowly. It can be obtained by reduction of glucose, which changes the converted aldehyde group (−CHO) to a primary alcohol g ...

xylitol Xylitol is a chemical compound with the formula , or HO(CH2)(CHOH)3(CH2)OH; specifically, one particular stereoisomer with that structural formula. It is a colorless or white crystalline solid that is freely soluble in water. It can be classifie ...

mannitol Mannitol is a type of sugar alcohol used as a sweetener and medication. It is used as a low calorie sweetener as it is poorly absorbed by the intestines. As a medication, it is used to decrease pressure in the eyes, as in glaucoma, and to lower ...

, and

maltitol Maltitol is a sugar alcohol (a polyol) used as a sugar substitute. It has 75–90% of the sweetness of sucrose (table sugar) and nearly identical properties, except for browning. It is used to replace table sugar because it is half as energetic, ...

are all sugar alcohols. The U.S.

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respon ...

(FDA) classifies sugar alcohols as " generally recognized as safe" (GRAS). They are approved as food additives, and are recognized as not contributing to

tooth decay Tooth decay, also known as cavities or caries, is the breakdown of teeth due to acids produced by bacteria. The cavities may be a number of different colors from yellow to black. Symptoms may include pain and difficulty with eating. Complicatio ...

or causing increases in

blood glucose Glycaemia, also known as blood sugar level, blood sugar concentration, or blood glucose level is the measure of glucose concentrated in the blood of humans or other animals. Approximately 4 grams of glucose, a simple sugar, is present in the blo ...

. Lactitol is also approved for use in foods in most countries around the world. Like other sugar alcohols, lactitol causes cramping, flatulence, and diarrhea in some individuals who consume it. This is because humans lack a suitable beta-galactosidase in the upper gastrointestinal (GI) tract, and a majority of ingested lactitol reaches the large intestine, where it then becomes fermentable to gut microbes (prebiotic) and can pull water into the gut by osmosis. Those with health conditions should consult their GP or dietician prior to consumption.

History

The U.S.

(FDA) approved Pizensy based on evidence from a clinical trial (Trial 1/ NCT02819297) of 594 subjects with CIC conducted in the United States. The FDA also considered other supportive evidence including data from Trial 2 (NCT02481947) which compared Pizensy to previously approved drug (lubiprostone) for CIC, and Trial 3 (NCT02819310) in which subjects used Pizensy for one year as well as data from published literature. The benefit and side effects of Pizensy were evaluated in a clinical trial (Trial 1) of 594 subjects with CIC. In this trial, subjects received treatment with either Pizensy or placebo once daily for 6 months. Neither the subjects nor the health care providers knew which treatment was being given until after the trials were completed. In the second trial (Trial 2) of three months duration, improvement in CSBMs was used to compare Pizensy to the drug

lubiprostone Lubiprostone (rINN, marketed under the trade name Amitiza among others) is a medication used in the management of chronic idiopathic constipation, predominantly irritable bowel syndrome-associated constipation in women and opioid-induced constip ...

which was previously approved for CIC. The third trial (Trial 3) was used to collect the side effects in subjects treated with Pizensy for one year.

References

External links

* * {{Portal bar , Medicine Disaccharides E-number additives Laxatives Sugar alcohols Sugar substitutes