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Комплекс из натуральных волокон снижает вес при избыточной массе тела и ожирении: двойное слепое рандомизированное плацебо-контролируемое исследование
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Аннотация
В доклинических исследованиях и в исследованиях с участием человека было показано, что патентованный комплекс из натуральных волокон (литрамин IQP G-002AS), полученный из опунции индийской (Opuntia ficus-indica) и стандартизованный в отношении липофильной активности понижает всасывание жира, содержащегося в пище, посредством связывания жиров в ЖКТ. В настоящей работе мы изучали эффективность и безопасность применения IQP G-002AS для снижения массы тела. В исследовании участвовали 125 взрослых пациентов с избыточной массой тела и ожирением. Участникам исследования была рекомендована физическая нагрузка, кроме того, пациентам давали рекомендации в отношении питания, включая планы гипокалорийной диеты (30% калорий из жиров и дефицит в 500 ккал в день). По окончании 2-недельной вводной фазы приема плацебо участники исследования были случайным образом распределены по группам лечения и получали IQP G-002AS или плацебо по 3 г в день. Первичным ожидаемым результатом являлось изменение массы тела по сравнению с исходным значением; вторичные ожидаемые результаты включали дополнительные показатели ожирения и параметры безопасности. Фазу лечения продолжительностью 12 нед завершили 123 участника (все пациенты, начавшие получать лечение: 30 мужчин и 93 женщины; средний индекс массы тела (ИМТ): 29,6±2,8 кг/м2 и средний возраст 45,4±11,3 года). Среднее изменение массы тела относительно исходного значения составило 3,8±1,8 кг в группе принимавших IQP G-002AS в сравнении с 1,4±2,6 кг в группе принимавших плацебо (p<0,001). В группе принимавших IQP G-002AS зарегистрировано больше участников, масса тела которых уменьшилась на 5% в сравнении с исходной массой, чем в группе принимавших плацебо (p=0,027). Кроме того, в сравнении с группой плацебо в группе наблюдалось значимо большее уменьшение ИМТ, содержания жира в организме и окружности талии. Комплекс IQP G-002AS хорошо переносился, его прием не сопровождался нежелательными побочными реакциями. Полученные результаты позволяют заключить, что комплекс из натуральных волокон литрамин IQP G-002AS эффективно стимулирует снижение массы тела.
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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 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 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 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 IQP G-002AS vs 1,4±2,6 kg in placebo (p<0,001). More IQP G-002AS subjects lost at least 5% of their initial body weight compared to placebo (p=0,027). Compared with placebo, IQP G-002AS also showed significantly greater reduction in BMI, body fat composition, and waist circumference. IQP G-002AS 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.
Полный текст
Список литературы
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30. 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: 1095–9.
2. 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: 557–67.
3. Uwaifo AGI, Editor C, Griffing GT. Obesity. Medscape Reference. 2011. Available at: <http://emedicine.medscape.com/article/123702-overview>
4. Wellman NS, Friedberg B. Causes and consequences of adult obesity: health, social and economic impacts in the United States. Asia Pac J ClinNutr 2002; 11 (Suppl. 8): S705–S709.
5. De Wit L, Luppino F, van Straten A et al. Depression and obesity: a metaanalysis of community-based studies. Psychiatry Res 2010; 178: 230–5.
6. Simon GE, Ludman EJ, Linde JA et al. Association between obesity and depression in middle-aged women. Gen Hosp Psychiatry 2008; 30: 32–9.
7. Simon GE, Von Korff M, Saunders K et al. Association between obesityand psychiatric disorders in the US adult population. Arch Gen Psychiatry 2006; 63: 824–30.
8. Wadden TA, Stunkard AJ. Social and psychological consequences of obesity. Ann Intern Med 1985; 103: 1062–7.
9. Hammond RA, Levine R. The economic impact of obesity in the United States. Diabetes Metab Syndr Obes 2010; 3: 285–95.
10. Fry J, Finley W. The prevalence and costs of obesity in the EU. Proc Nutr Soc 2005; 64: 359–62.
11. Bray GA, Paeratakul S, Popkin BM. Dietary fat and obesity: a review of animal, clinical and epidemiological studies. Physiol Behav 2004; 83: 549–55.
12. 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: 167–72.
13. 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: 235–42.
14. Rössner S, Sjöström L, Noack R et al. 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.
15. Hauptman J, Lucas C, Boldrin MN et al. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med 2000; 9: 160–7.
16. Collazo-Clavell ML. Safe and effective management of the obese patient. Mayo Clin Proc 1999; 74: 1255–9; quiz 1259.
17. Johansson K, Neovius K, DeSantis SM et al. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. Obes Rev 2009; 10: 564–75.
18. US Food and Drug Administration. Safety orlistat (marketed as Alli and Xenical): early communication about an ongoing safety review, 2009; p. 180057.
19. Bachmann C. Ein Fasernkomplex zur Gewichts- reduktion und -kontrolle. Ars Medici thema Phytotherapie 2010: 25–7.
20. International Association for the Study of Obesity. Overweight and Obesity in the EU27. International Association for the Study of Obesity: London, 2008.
21. Trumbo P, Schlicker S, Yates AA, Poos M. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and aminoacids. J Am Diet Assoc 2002; 102: 1621–30.
22. Drent ML, van der Veen EA. Lipase inhibition: a novel concept in the treatment of obesity. Int J Obes Relat Metab Disord 1993; 17: 241–4.
23. 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 JObes Relat Metab Disord 1995; 19: 221–6.
24. US Food and Drug Administration. guidance for industry developing products for weight management guidance for industry developing products for weight management. 2007.
25. 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.
26. Phelan S, Wadden TA, Berkowitz RI et al. Impact of weight loss on the metabolic syndrome. Int J Obes (Lond) 2007; 31: 1442–8.
27. Jull AB, Rodgers A, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev 2008: CD005083.
28. 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: 125–32.
29. 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: 959–66.
30. 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: 1095–9.
________________________________________________
1. Stevens G, Mascarenhas M, Mathers C. Global health risks: progress and challenges. Bull World Health Organ 2009; 87: 646.
2. 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: 557–67.
3. Uwaifo AGI, Editor C, Griffing GT. Obesity. Medscape Reference. 2011. Available at: <http://emedicine.medscape.com/article/123702-overview>
4. Wellman NS, Friedberg B. Causes and consequences of adult obesity: health, social and economic impacts in the United States. Asia Pac J ClinNutr 2002; 11 (Suppl. 8): S705–S709.
5. De Wit L, Luppino F, van Straten A et al. Depression and obesity: a metaanalysis of community-based studies. Psychiatry Res 2010; 178: 230–5.
6. Simon GE, Ludman EJ, Linde JA et al. Association between obesity and depression in middle-aged women. Gen Hosp Psychiatry 2008; 30: 32–9.
7. Simon GE, Von Korff M, Saunders K et al. Association between obesityand psychiatric disorders in the US adult population. Arch Gen Psychiatry 2006; 63: 824–30.
8. Wadden TA, Stunkard AJ. Social and psychological consequences of obesity. Ann Intern Med 1985; 103: 1062–7.
9. Hammond RA, Levine R. The economic impact of obesity in the United States. Diabetes Metab Syndr Obes 2010; 3: 285–95.
10. Fry J, Finley W. The prevalence and costs of obesity in the EU. Proc Nutr Soc 2005; 64: 359–62.
11. Bray GA, Paeratakul S, Popkin BM. Dietary fat and obesity: a review of animal, clinical and epidemiological studies. Physiol Behav 2004; 83: 549–55.
12. 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: 167–72.
13. 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: 235–42.
14. Rössner S, Sjöström L, Noack R et al. 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.
15. Hauptman J, Lucas C, Boldrin MN et al. Orlistat in the long-term treatment of obesity in primary care settings. Arch Fam Med 2000; 9: 160–7.
16. Collazo-Clavell ML. Safe and effective management of the obese patient. Mayo Clin Proc 1999; 74: 1255–9; quiz 1259.
17. Johansson K, Neovius K, DeSantis SM et al. Discontinuation due to adverse events in randomized trials of orlistat, sibutramine and rimonabant: a meta-analysis. Obes Rev 2009; 10: 564–75.
18. US Food and Drug Administration. Safety orlistat (marketed as Alli and Xenical): early communication about an ongoing safety review, 2009; p. 180057.
19. Bachmann C. Ein Fasernkomplex zur Gewichts- reduktion und -kontrolle. Ars Medici thema Phytotherapie 2010: 25–7.
20. International Association for the Study of Obesity. Overweight and Obesity in the EU27. International Association for the Study of Obesity: London, 2008.
21. Trumbo P, Schlicker S, Yates AA, Poos M. Dietary reference intakes for energy, carbohydrate, fiber, fat, fatty acids, cholesterol, protein and aminoacids. J Am Diet Assoc 2002; 102: 1621–30.
22. Drent ML, van der Veen EA. Lipase inhibition: a novel concept in the treatment of obesity. Int J Obes Relat Metab Disord 1993; 17: 241–4.
23. 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 JObes Relat Metab Disord 1995; 19: 221–6.
24. US Food and Drug Administration. guidance for industry developing products for weight management guidance for industry developing products for weight management. 2007.
25. 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.
26. Phelan S, Wadden TA, Berkowitz RI et al. Impact of weight loss on the metabolic syndrome. Int J Obes (Lond) 2007; 31: 1442–8.
27. Jull AB, Rodgers A, Walker N. Honey as a topical treatment for wounds. Cochrane Database Syst Rev 2008: CD005083.
28. 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: 125–32.
29. 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: 959–66.
30. 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: 1095–9.
Авторы
Барбара Грубе1, Пи-Вин Чонг2, Кей-Цзиа Лау2, Ханс-Дитер Орцеховски3
1. Общая медицинская практика, Берлин, Германия;
2. Отдел исследований и разработки, Инкьюфарм Юроп Лтд., Лондон, Великобритания;
3. Институт клинической фармакологии и токсикологии, Университетский медицинский комплекс «Шарите», Берлин, Германия
1. Общая медицинская практика, Берлин, Германия;
2. Отдел исследований и разработки, Инкьюфарм Юроп Лтд., Лондон, Великобритания;
3. Институт клинической фармакологии и токсикологии, Университетский медицинский комплекс «Шарите», Берлин, Германия
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Barbara Grube, Pee-Win Chong, Kai-Zhia Lau, Hans-Dieter Orzechowski
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