Obesity, the fifth leading risk of death worldwide is defined as an excessive fat accumulation that is associated with chronic medical conditions, which reduces life expectancy (1
). It results from a level of energy intake, which exceeds the body's energy expenditure. Obesity and overweight are attributed to 44% of diabetes cases, to 23% of ischemic heart disease cases, and to 7-41% of certain cancers, such as colon cancer and breast cancer (1
). Obesity is considered as an epidemic public health problem irrespective of genders, ethnicity, and age, affecting one in 10 adults worldwide (2
There are currently 100 million overweight and obese adults in the United States, while the Multinational Monitoring of Trends and Determinants in Cardiovascular Disease (MONICA) project suggested that at least 15% of men and 22% of women in Europe are obese. Similar data are reported from many developing countries (including China, Malaysia, and part of South America). Unlike the developed countries, the socioeconomic status in these developing countries is positively correlated with the prevalence of obesity, which is regarded as an indicator of wealth (3
The tremendous increase of obesity prevalence and incidence in the past two decades has cast a shadow over the world's socioeconomic state (4
). Obesity is associated with depression (5
), which may be caused by disparagement of body image and negative emotional reactions to dieting (8
). According to a 2010 review, total direct and indirect annual costs of obesity in the United States was at least USD 215 billion (9
); while the total direct and indirect annual costs of obesity in 15 European Commission countries was ~32.8 billion Euros in 2002 (10
However, reducing the total caloric intake can prevent obesity and overweight. Previous studies have suggested that, apart from high carbohydrate intake, excessive intake of dietary fat (along with insufficient physical activity) plays a major role in causing obesity (11
). Therefore, treatments to reduce the intestinal uptake of dietary fat continue to be an effective approach in weight management.
However, there is limited choice of effective and safe agents for reducing dietary fat absorption. Lipase inhibitors are generally approved by the health authorities in promoting weight loss by reducing the absorption of dietary fat via pancreatic lipase inhibition (12
). However, this pharmacotherapy is associated with gastrointestinal (GI) side effects such as fecal incontinence, flatus with discharge, oily spotting (13
), and liver injury (18
). Meanwhile, nonpharmacological options, such as intake of dietary fiber, are of growing interest. However, poor product characterization and lack of evidence from clinical research have questioned efficacy of dietary fiber.
Litramine IQP G-002AS is a natural fiber complex derived from Opuntia ficus-indica
, enriched with additional soluble fiber from Acacia spp
. IQP G-002AS is standardized for its lipophilic activity and has been shown to reduce the dietary fat absorption through GI fat binding. The lipophilic IQP G-002AS binds to dietary fat, forming fat−fiber complexes, which are not absorbed by the intestine and, hence, are eliminated (19
The fat-binding efficacy of IQP G-002AS was previously shown in in vitro
GI models, animal studies, and human studies, where IQP G-002AS showed a reduction of dietary fat absorption up to 27% (19
In this study, we investigated the efficacy and safety of IQP G-002AS in a randomized controlled trial to test the hypothesis that the intake of IQP G-002AS promotes increased weight loss compared to placebo in overweight and moderately obese human subjects.