Abstract
ObjectiveA proprietary natural fiber complex (Litramine IQP G-002AS) derived from Opuntia ficus-indica, and standardized on lipophilic activity, was previously shown in preclinical and human studies to reduce dietary fat absorption through gastrointestinal (GI) fat binding. Here, we investigated the efficacy and safety of IQP G-002AS in body weight reduction.Design and MethodsOne hundred twenty-five overweight and obese adults participated in the study. Subjects were advised on physical activity, and received nutritional counseling, including hypocaloric diet plans (30% energy from fat and 500 kcal deficit/day). After a 2-week placebo run-in phase, subjects were randomized to receive either 3 g/day of IQP G-002AS (IQ) or a placebo. The primary endpoint was change in body weight from baseline; secondary endpoints included additional obesity measures and safety parameters.ResultsOne hundred twenty-three subjects completed the 12-week treatment phase (intention-to-treat (ITT) population: 30 male and 93 female; mean BMI: 29.6 ± 2.8 kg/m2 and age: 45.4 ± 11.3 years). The mean body weight change from baseline was 3.8 ± 1.8 kg in IQ vs. 1.4 ± 2.6 kg in placebo (P < 0.001). More IQ subjects lost at least 5% of their initial body weight compared to placebo (P = 0.027). Compared with placebo, IQ also showed significantly greater reduction in BMI, body fat composition, and waist circumference. IQ was well tolerated with no adverse reactions reported.ConclusionsThese results suggest that the natural fiber complex Litramine IQP G-002AS is effective in promoting weight loss.
Highlights
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]
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
The primary objective of this study was to demonstrate the efficacy of IQP G-002AS to induce weight loss over a period of 12 weeks in overweight and obese subjects
Summary
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]. 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. The socioeconomic status in these developing countries is positively correlated with the prevalence of obesity, which is regarded as an indicator of wealth [3]
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