A natural fiber complex reduces body weight in the overweight and obese: a double-blind, randomized, placebo-controlled study

Barbara Grube, Pee-Win Chong, Kai-Zhia Lau, Hans-Dieter Orzechowski, Barbara Grube, Pee-Win Chong, Kai-Zhia Lau, Hans-Dieter Orzechowski

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.

Design and 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.

Trial registration: ClinicalTrials.gov NCT01233349.

Copyright © 2012 The Obesity Society.

Figures

FIGURE 1
FIGURE 1
Study design and disposition of subjects. ITT, intention-to-treat.
FIGURE 2
FIGURE 2
Body weight reduction over time. All data are presented as mean ± s.e.m. Asterisks denote significant difference (P < 0.001) of body weight between IQP G-002AS and placebo (derived from ANOVA).
FIGURE 3
FIGURE 3
Percentage of subjects who lost at least 3, 5, and 10% of initial body weight. Asterisks denote significant difference between IQP G-002AS and placebo (derived from χ2).

References

    1. Stevens G, Mascarenhas M, Mathers C. Global health risks: progress and challenges. Bull World Health Organ. 2009;87:646.
    1. Finucane MM, Stevens GA, Cowan MJ, et al. National, regional, and global trends in body-mass index since 1980: systematic analysis of health examination surveys and epidemiological studies with 960 country-years and 9·1 million participants. Lancet. 2011;377:557–567.
    1. Uwaifo AGI, Editor C, Griffing GT. Obesity. Medscape Reference. 2011. Available at: < >. Accessed 20 August 2011.
    1. Wellman NS, Friedberg B. Causes and consequences of adult obesity: health, social and economic impacts in the United States. Asia Pac J Clin Nutr. 2002;11(Suppl 8):S705–S709.
    1. de Wit L, Luppino F, van Straten A, et al. Depression and obesity: a meta-analysis of community-based studies. Psychiatry Res. 2010;178:230–235.
    1. Simon GE, Ludman EJ, Linde JA, et al. Association between obesity and depression in middle-aged women. Gen Hosp Psychiatry. 2008;30:32–39.
    1. Simon GE, Von Korff M, Saunders K, et al. Association between obesity and psychiatric disorders in the US adult population. Arch Gen Psychiatry. 2006;63:824–830.
    1. Wadden TA, Stunkard AJ. Social and psychological consequences of obesity. Ann Intern Med. 1985;103:1062–1067.
    1. Hammond RA, Levine R. The economic impact of obesity in the United States. Diabetes Metab Syndr Obes. 2010;3:285–295.
    1. Fry J, Finley W. The prevalence and costs of obesity in the EU. Proc Nutr Soc. 2005;64:359–362.
    1. Bray GA, Paeratakul S, Popkin BM. Dietary fat and obesity: a review of animal, clinical and epidemiological studies. Physiol Behav. 2004;83:549–555.
    1. Sjöström L, Rissanen A, Andersen T, et al. Randomised placebo-controlled trial of orlistat for weight loss and prevention of weight regain in obese patients. European Multicentre Orlistat Study Group. Lancet. 1998;352:167–172.
    1. Davidson MH, Hauptman J, DiGirolamo M, et al. Weight control and risk factor reduction in obese subjects treated for 2 years with orlistat: a randomized controlled trial. JAMA. 1999;281:235–242.
    1. Rössner S, Sjöström L, Noack R, Meinders AE, Noseda G. Weight loss, weight maintenance, and improved cardiovascular risk factors after 2 years treatment with orlistat for obesity. European Orlistat Obesity Study Group. Obes Res. 2000;8:49–61.
    1. Hauptman J, Lucas C, Boldrin MN, Collins H, Segal KR. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med. 2000;9:160–167.
    1. Collazo-Clavell ML. Safe and effective management of the obese patient. Mayo Clin Proc. 1999;74:1255–9; quiz 1259.
    1. Johansson K, Neovius K, DeSantis SM, Rössner S, Neovius M. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. Obes Rev. 2009;10:564–575.
    1. US Food and Drug Administration. Safety orlistat (marketed as Alli and Xenical): early communication about an ongoing safety review. 2009. pp. 180057–180057.
    1. Bachmann C. Ein Fasernkomplex zur Gewichts- reduktion und -kontrolle. Ars Medici thema Phytotherapie. 2010:25–27.
    1. International Association for the Study of Obesity. Overweight and Obesity in the EU27. 2008. International Association for the Study of Obesity: London.
    1. Trumbo P, Schlicker S, Yates AA, Poos M. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and amino acids. J Am Diet Assoc. 2002;102:1621–1630.
    1. Drent ML, van der Veen EA. Lipase inhibition: a novel concept in the treatment of obesity. Int J Obes Relat Metab Disord. 1993;17:241–244.
    1. Drent M, Larsson I, William-Olsson T, et al. Orlistat (Ro 18-0647), a lipase inhibitor, in the treatment of human obesity: a multiple dose study. Int J Obes Relat Metab Disord. 1995;19:221–226.
    1. US Food and Drug Administration. 2007. guidance for industry developing products for weight management guidance for industry developing products for weight management.
    1. National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI), North American Association for the Study of Obesity (NAASO) The practical guide: Identification, evaluation and treatment of overweight and obesity in adults. 2000.
    1. Phelan S, Wadden TA, Berkowitz RI, et al. Impact of weight loss on the metabolic syndrome. Int J Obes (Lond) 2007;31:1442–1448.
    1. Jull AB, Rodgers A, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev. 2008:CD005083.
    1. Van Gaal LF, Broom JI, Enzi G, Toplak H. Efficacy and tolerability of orlistat in the treatment of obesity: a 6-month dose-ranging study. Orlistat Dose-Ranging Study Group. Eur J Clin Pharmacol. 1998;54:125–132.
    1. Romero-Corral A, Virend K, Sierra-Johnson J, et al. Accuracy of body mass index to diagnose obesity in the US adult population. Int J Obes (Lond) 2008;32:959–966.
    1. Cavaliere H, Floriano I, Medeiros-Neto G. Gastrointestinal side effects of orlistat may be prevented by concomitant prescription of natural fibers (psyllium mucilloid) Int J Obes Relat Metab Disord. 2001;25:1095–1099.

Source: PubMed

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