title: A natural fiber complex reduces body weight in the overweight and obese: a double-blind, randomized, placebo-controlled study.
abstract: OBJECTIVE
  A 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.
  
  
  METHODS
  One 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.
  
  
  RESULTS
  One 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/m(2) 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.
  
  
  CONCLUSIONS
  These results suggest that the natural fiber complex Litramine IQP G-002AS is effective in promoting weight loss.
authors.affiliation: Practice for General Medicine, Berlin, Germany.
authors.forename: Barbara
authors.initials: B
authors.lastname: Grube
authors.forename: Pee-Win
authors.initials: PW
authors.lastname: Chong
authors.forename: Kai-Zhia
authors.initials: KZ
authors.lastname: Lau
authors.forename: Hans-Dieter
authors.initials: HD
authors.lastname: Orzechowski
mesh_terms: D000273:Adipose Tissue / Q000187:drug effects*; D000328:Adult; D019440:Anti-Obesity Agents / Q000494:pharmacology / Q000627:therapeutic use; D001823:Body Composition / Q000187:drug effects; D015992:Body Mass Index; D004043:Dietary Fiber / Q000494:pharmacology / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D057194:Intention to Treat Analysis; D008297:Male; D008875:Middle Aged; D009765:Obesity / Q000178:diet therapy*; D029747:Opuntia / Q000737:chemistry*; D050177:Overweight / Q000178:diet therapy; D008517:Phytotherapy; D028321:Plant Preparations / Q000494:pharmacology / Q000627:therapeutic use; D055105:Waist Circumference / Q000187:drug effects*; D015431:Weight Loss / Q000187:drug effects*
chemical_list: D019440:Anti-Obesity Agents; D004043:Dietary Fiber; D028321:Plant Preparations