A Natural Fiber Complex Reduces Body Weight in the Overweight and Obese: A Double-Blind, Randomized, Placebo-Controlled Study

Practice for General Medicine, Berlin, Germany.
Obesity (Impact Factor: 3.73). 03/2013; 21(1):58-64. DOI: 10.1002/oby.20244
Source: PubMed


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.
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.
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.
These results suggest that the natural fiber complex Litramine IQP G-002AS is effective in promoting weight loss.

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Available from: Kai-Zhia Lau, Oct 09, 2014
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    • "The resulting fat-fibre complexes are not readily absorbed through the gastrointestinal tract and are eventually excreted through the faeces [12]. A previous randomised, placebocontrolled study has shown that the intake of Litramine successfully reduced body weight through the abovementioned mechanism [13]. However, the weight maintenance effect of Litramine has yet to be proven in clinical trial. "
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    ABSTRACT: Litramine (IQP-G-002AS) was shown to be effective and safe for weight loss in overweight and obese subjects. However, long-term effectiveness on maintenance of body weight loss has yet to be ascertained. Objective. To assess effect of Litramine on maintenance of body weight loss. Methods. A double-blind, randomised, placebo-controlled trial on overweight and obese patients was conducted over two sites in Germany for 24 weeks. Subjects with documented previous weight loss of 3% over the last 3–6 months were randomised to groups given either Litramine (3 g/day) or a matching placebo. Primary endpoints were difference of mean body weight (kg) between baseline and end of study and maintenance of initially lost body weight in verum group, where maintenance is defined as ≤1% weight gain. Results. Subjects who were taking Litramine lost significantly more body weight compared to the subjects taking placebo who gained weight instead ( - 0.62 ± 1.55 kg versus 1.62 ± 1.48 kg, p < 0.001 ). More importantly, 92% of subjects in Litramine group were able to maintain their body weight after initial weight loss, versus 25% in placebo group. No serious adverse events were reported throughout. Conclusion. Litramine is effective and safe for long-term body weight maintenance. Trial Registration. This trial is registered with identifier: NCT01505387 .
    Full-text · Article · Sep 2015 · Journal of obesity
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    • "P = 0.280) Maki KC, et al., 2007 ID Bell LP, et al., 1990 Schwab U, et al., 2006 Subtotal (I-squared = 32.0%, P = 0.172) High (more than 10 g) Birketvedt GS, et al., 2000 Wood RJ, et al., 2007 Grube B, et al., 2013 Subtotal (I-squared = 56.9%, P = 0.041) Lehtimaki T, et al., 2005 (E4 non-carrier) Kristensen M, et al., 2011 Medium (4–10 g) de Bock M, et al., 2012 Low (up to 3 g) "
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    ABSTRACT: To determine the effect of different types of dietary fibre on SBP and DBP. A systematic review of the literature and a meta-analysis of randomized controlled trials using random-effects models. Eligibility criteria for studies included randomized controlled trials of at least 6 weeks duration, testing a fibre isolate or fibre-rich diet against a control or placebo published between 1 January 1990 and 1 December 2013. Twenty-eight trials met the inclusion criteria and reported fibre intake and SBP and/or DBP. Eighteen trials were included in a meta-analysis. Studies were categorized into 1 of 12 fibre-type categories. The pooled estimates for all fibre types were -0.9 mmHg [95% confidence interval (CI) -2.5 to 0.6 mmHg] and -0.7 mmHg (95% CI -1.9 to 0.5 mmHg) for SBP and DBP, respectively. The median difference in total fibre was 6 g. Analyses of specific fibre types concluded that diets rich in beta-glucans reduce SBP by 2.9 mmHg (95% CI 0.9 to 4.9 mmHg) and DBP by 1.5 mmHg (95% CI 0.2 to 2.7 mmHg) for a median difference in beta-glucans of 4 g. Heterogeneity for individual fibre types was generally low. Higher consumption of beta-glucan fibre is associated with lower SBP and DBP. The results of this review are consistent with recommendations to increase consumption of foods rich in dietary fibre, but some additional emphasis on sources of beta-glucans, such as oats and barley, may be warranted.
    Full-text · Article · Feb 2015 · Journal of Hypertension
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    • "As quoted above, the reported fecal fat excretion of orlistat at 180 mg/d is 25%, yet in a study of 16 weeks’ duration, orlistat at 60 mg TID has been shown to only result in a 3.50 kg weight loss compared with 1.90 kg in the placebo group, with a net weight loss of 1.6 kg.36 In comparison, 2.4 kg mean net body weight loss was observed over a 3-month period during a previous study of cactus fiber,21 suggesting a more pronounced weight loss effect size than explained by the reduced energy intake due to fat excretion alone. The additional weight loss effect may be attributed to other functional properties of fibers contained in cactus fiber; for example, the effects of fibers on promoting satiety37,38 and delaying absorption of nutrients during digestion,32,33,39 which have been frequently reported in literature. "
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    ABSTRACT: Background Cactus (Opuntia ficus-indica) fiber was shown to promote weight loss in a 3-month clinical investigation. As demonstrated by in vitro studies, cactus fiber binds to dietary fat and its use results in reduced absorption, which in turn leads to reduced energy absorption and ultimately the reduction of body weight. Objective The objective of our study was to elucidate the dietary fat binding capacity of cactus fiber through determination of fecal fat excretion in healthy volunteers. Subjects and Methods This clinical investigation was performed as a double-blind, randomized, placebo-controlled, crossover study in healthy subjects for a period of approximately 45 days. Twenty healthy volunteer subjects were randomized to receive cactus fiber or placebo, 2 tablets thrice daily with main meals. All subjects were provided with meals during the study period (except washout) according to a standardized meal plan, with 35% of daily energy need coming from fat. Two 24-hour feces samples were collected during both the baseline and treatment periods for analysis of the fat content. Results Cactus fiber showed an increased fecal fat excretion compared with placebo (mean [SD] = 15.79% [5.79%] vs 4.56% [3.09%]; P < 0.001). No adverse events were reported throughout the study period. Conclusions Cactus fiber has been shown to significantly promote fecal fat excretion in healthy adults. The results of our study support the hypothesis that cactus fiber helps in reducing body weight by binding to dietary fat and increasing its excretion, thus reducing dietary fat available for absorption. identifier: NCT01590667.
    Full-text · Article · Dec 2014 · Current Therapeutic Research
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