Lactitol is a
sugar alcohol used as a replacement bulk
sweetener 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. Lactitol is produced by two manufacturers,
Danisco and
Purac Biochem.
Applications
Lactitol is used in a variety of low
food energy or
low fat 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
A sugar substitute is a food additive that provides a sweetness like that of sugar while containing significantly less food energy than sugar-based sweeteners, making it a zero-calorie () or low-calorie sweetener. Artificial sweeteners may be d ...
candies,
cookies (biscuits),
chocolate, and
ice cream, 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
kilojoules) per
gram,
compared to 4 kilocalories (17 kJ) per gram for typical
saccharides. Hence, lactitol is about 60% as caloric as typical saccharides.
Medical
Lactitol is listed as an
excipient in some prescription drugs.
Lactitol is a laxative and is used to prevent or treat
constipation, 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 husk is an approved combination for
idiopathic constipation as a laxative and is used to prevent or treat constipation.
Safety and health
Lactitol,
erythritol,
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,
mannitol, and
maltitol are all sugar alcohols. The U.S.
Food and Drug Administration (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 or causing increases in
blood glucose. 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.
Food and Drug Administration (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
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{{Portal bar , Medicine
Disaccharides
E-number additives
Laxatives
Sugar alcohols
Sugar substitutes