Effects of cactus fiber on the excretion of dietary fat in healthy subjects: a double blind, randomized, placebo-controlled, crossover clinical investigation

Ralf Uebelhack, Regina Busch, Felix Alt, Zhi-Ming Beah, Pee-Win Chong, Ralf Uebelhack, Regina Busch, Felix Alt, Zhi-Ming Beah, Pee-Win Chong

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. ClinicalTrials.gov identifier: NCT01590667.

Keywords: Opuntia ficus-indica; dietary fat; fat binding; fat excretion; obesity; weight management.

Figures

Figure 1
Figure 1
Clinical trial study schedule comparing and analyzing the fecal fat extraction effect of cactus fiber. There were 6 clinical visits (V1–V6) throughout the study period. V1 = screening + blood sampling; V2 = Baseline 1 (subjects were given a standardized meal, with placebo); V3 = subjects compliant to the meal plan and investigational product regimen were randomized to receive cactus fiber or placebo and a 7-day washout period followed; V4 = baseline 2 (similar to Baseline 1); V5 = subjects compliant to the meal plan and investigational product regimen were crossed over to the second treatment arm; V6 = blood sampling. Stool was collected on both Day 5 and Day 6, or Day 6 and Day 7 of baseline and intervention period. IP = investigational product.
Figure 2
Figure 2
Subject flow diagram. Twenty-one subjects were screened and 20 subjects were randomized. All 20 subjects were included in the analysis.
Figure 3
Figure 3
Percentage of dietary fat excreted (in relation to total fat intake). Error bar represents 1 standard error of mean. With cactus fiber, mean (SD) 15.79% (5.79%) of fat was excreted, in comparison with placebo, which contributed 4.56% (3.09%) of fat excretion (P < 0.001). *Significant difference.

References

    1. World Health Organization . World Health Organization; Geneva, Switzerland: 2000. Obesity: preventing and managing the global epidemic. W.H.O. Technical Report Series 894.
    1. World Health Organization. Obesity and overweight. . Accessed November 8, 2013.
    1. Weight-Control Information Network. Overweight and obese statistics. . Accessed January 24, 2014.
    1. Eurostat. Overweight and obesity – BMI statistics. . Accessed November 8, 2013.
    1. Pi-Sunyer F.X. Medical hazards of obesity. Ann Intern Med. 1993;119(7 Pt 2):655–660.
    1. National Heart, Lung and Blood Institute . National Institutes of Health; Washington, DC: 1998. Clinical Guidelines on the Identification, Evaluation and Treatment of Overweight and Obesity in Adults.
    1. Formiguera X., Cantón A. Obesity: epidemiology and clinical aspects. Best Pract Res Clin Gastroenterol. 2004;18:11125–11146.
    1. Lewis S., Thomas S.L., Blood R.W., Castle D.J., Hyde J., Komesaroff P.A. How do obese individuals perceive and respond to the different types of obesity stigma that they encounter in their daily lives? A qualitative study. Soc Sci Med. 2011;73:1349–1356.
    1. Bray G.A., Paeratakul S., Popkin B.M. Dietary fat and obesity: a review of animal, clinical and epidemiological studies. Physiol Behav. 2004;83:549–555.
    1. Ravussin E., Tataranni P.A. Dietary fat and human obesity. J Am Diet Assoc. 1997;97(7 Suppl):S42–S46.
    1. Swinburn B., Ravussin E. Energy balance or fat balance? Am J Clin Nutr. 1993;57(Suppl):766S–771S.
    1. Ballinger A., Peikin S.R. Orlistat: its current status as an anti-obesity drug. Eur J Pharmacol. 2002;440:109–117.
    1. Ballinger A. Orlistat in the treatment of obesity. Expert Opin Pharmacother. 2000;1:841–847.
    1. US Food and Drug Administration. Orlistat (marketed as Alli and Xenical): labelling change. . Accessed November 8, 2013.
    1. Tesoriere L., Butera D., Pintaudi A.M. Supplementation with cactus pear (Opuntia ficus-indica) fruit decreases oxidative stress in healthy humans: a comparative study with vitamin C. Am J Clin Nutr. 2004;80:391–395.
    1. Madrigal-Santillán E., García-Melo F., Morales-González J.A. Antioxidant and anticlastogenic capacity of prickly pear juice. Nutrients. 2013;5:4145–4158.
    1. Budinsky A., Wolfram R., Oguogho A. Regular ingestion of Opuntia robusta lowers oxidation injury. Prostaglandins Leukot Essent Fatty Acids. 2001;65:45–50.
    1. Díaz-Medina E.M., Martín-Herrera D., Rodríguez-Rodríguez E.M., Díaz-Romero C. Chromium (III) in cactus pad and its possible role in the antihyperglycemic activity. J Funct Foods. 2012:311–314.
    1. Ayadi M.A., Abdelmaksoud W., Ennouri M., Attia H. Cladodes from Opuntia ficus indica as a source of dietary fibre: effect on dough characteristics and cake making. Indus Crops Products. 2009:40–47.
    1. Bachmann C. Ein Fasernkomplex zur Gewichtsreduktion und kontrolle. Ars Medici Thema Phytotherapie. 2010:25–27.
    1. Grube B., Chong P.W., Lau K.Z., Orzechowski H.D. A natural fiber complex reduces body weight in the overweight and obese: a double-blind, randomized, placebo-controlled study. Obesity. 2013;21:58–64.
    1. Gades M.D., Stern J.S. Chitosan supplementation and fecal fat excretion in men. Obes Res. 2003;11:683–688.
    1. Hsu T.F., Kusumoto A., Abe K. Polyphenol-enriched oolong tea increase fecal lipid excretion. Eur J Clin Nutr. 2006;60:1330–1336.
    1. ICH E6 (R1). . Accessed November 8, 2013
    1. ICH E3. . Accessed November 8, 2013
    1. Institute of Medicine . The National Academy Press; Washington, DC: 2005. Food and Nutrition Board. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids (Macronutrients)
    1. Mashio C., Tomei E., Leonardis B. NIRA. Clin Med (Bologna) 1984;65:133–147.
    1. Zhi J., Melia A.T., Guerciolini R. Retrospective population-based analysis of the dose-response (fecal fat excretion) relationship of orlistat in normal and obese volunteers. Clin Pharmacol Ther. 1994;56:82–85.
    1. European Medicines Agency. Assessment Report – Alli. EMA/CHMP/547710/2010. . Accessed October 31, 2013.
    1. Kristensen M., Jensen M.G., Aarestrup J. Flaxseed dietary fibers lower cholesterol and increase fecal fat excretion, but magnitude of effect depends on food type. Nutr Metab. 2012;9:8.
    1. Peña-Valdivia C., Trejo C., Arroyo-Peña V. Diversity of unavailable polysaccharides and dietary fiber in domesticated nopalito and cactus pear fruit (Opuntia spp.) Chem Biodiv. 2012;9:1599–1610.
    1. Hernández-Urbiola M.I., Pérez-Torrero E., Rodríguez-García M.E. Chemical analysis of nutritional content of prickly pads (Opuntia ficus-indica) at varied ages in an organic harvest. Int J Environ Res Public Health. 2011;8:1287–1295.
    1. Sáenz C. Cladodes: a source of dietary fiber. J Prof Assoc Cactus Dev. 1997;2:117–123.
    1. Bendsen N.T., Hother A.-L., Jensen S.K., Lorenzen J.K., Astrup A. Effect of diary calcium on fecal fat excretion: a randomized crossover trial. Int J Obes. 2008;32:1816–1824.
    1. Hall K.D., Heymsfield S.B., Kemnitz J.W. Energy balance and its components: implications for body weight regulation. Am J Clin Nutr. 2012;95:989–994.
    1. Anderson J.W., Schwartz S.M., Haupman J. Low-dose orlistat effects on body weight of mildly to moderately overweight individuals: a 16 week, double-blind, placebo-controlled trial. Ann Pharmacother. 2006;40:1717–1723.
    1. Slavin J., Green H. Dietary fibre and satiety. Nutr Bull. 2007;32(Suppl s1):32–42.
    1. Burley V.J., Paul A.W., Blundell J.E. Influence of a high-fibre food (myco-protein) on appetite: effects on satiation (within meals) and satiety (following meals) Eur J Clin Nutr. 1993;47:409–418.
    1. Godard M., Ewing B., Pischel I. Acute blood glucose lowering effects and long-term safety of Opuntia supplementation in pre-diabetic males and females. J Ethnopharmacol. 2010:1–2.
    1. Cummings J.H., Bingham S.A., Heaton K.W., Eastwood M.A. Fecal weight, colon cancer risk, and dietary intake of nonstarch polysaccharides (dietary fiber) Gastroenterology. 1992;103:1783–1789.

Source: PubMed

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