Healthy Effects of an Innovative Probiotic Pasta (SFLABPASTA)
Обзор исследования
Статус
Условия
Вмешательство/лечение
Подробное описание
Epidemiological evidences indicate that consumption of whole grains products is associated to a decreased risk for common chronic diseases, as cardiovascular diseases, diabetes, obesity, hypertension and metabolic syndrome. In the present study a whole grain pasta was supplemented with prebiotics and probiotics 'ad hoc' formulated. In detail, pasta was industrially developed after the identification of particular cultivars of wheat and barley, rich in carotenoids, β-glucans (2.6 g/100g pasta), not soluble fibers and antioxidants. Further, pasta was supplemented with spores of Bacillus coagulans, a putative probiotic microorganism, belonging to Lactobacillus family. It is well demonstrated the ability of this microorganism to survive to technological processes and to upper gastro-intesinal tract, in order to exert beneficial effects in the lower gut, as anti-microbial activity, increasing immunological defences as well as improvements in intestinal regularity. Conversely, the control pasta was made from the same cultivar of grain and by the same technological process, but without any supplementation.
In this parallel randomized controlled one arm trial, 40 healthy volunteers were randomly allocated for the consumption of the two kind of pasta once a day, for 12 weeks. At the beginning of the study and every 4 weeks, subjects were asked to provide blood, urine and feces for the evaluation of:
- blood inflammation markers;
- blood lipid and carbohydrate profile;
- blood and urine markers of cardiovascular risk;
- feces profile of microbiota and detection of markers for the healthiness of the gut.
In addition, volunteers filled in different questionnaires regarding their dietary habits, the physical activity and the gut healthiness.
Тип исследования
Регистрация (Действительный)
Фаза
- Непригодный
Контакты и местонахождение
Места учебы
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Parma, Италия, 43124
- University of Parma
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PR
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Parma, PR, Италия, 43124
- University of Parma - Department of Food Sciences
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Описание
Inclusion Criteria:
- Overweight / Obesity
- Lower consumers of fruit and vegetables
Exclusion Criteria:
- Antibiotic treatment within 3 months prior the pasta feeding
- Chronic diseases
- Surgeries
- Consumer of whole grain products
- Dieting
- Pregnant or lactating
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Одинокий
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Плацебо Компаратор: Control pasta
Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.
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Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
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Экспериментальный: Probiotic Whole Grain Pasta
Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks.
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Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Variation of plasma lipids
Временное ограничение: 12 weeks
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Measure of plasma concentrations (mg/dL) of Total-, LDL-, and HDL-Cholesterol; Measure of plasma concentrations (µg/mL) of Non Esterified Fatty Acids (NEFA), Esterified Fatty Acids (EFA) and Short Chain Fatty Acids (SCFA). Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered. |
12 weeks
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Variation of fecal microbiota composition
Временное ограничение: 12 weeks
|
By FISH (colony-forming unit, CFU/g). Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered. |
12 weeks
|
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Variation of antioxidant activity on fecal waters
Временное ограничение: 12 weeks
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Measure of fecal waters FRAP (µmol/L) and TEAC (µmol/L) concentrations. Statistical analysis of the primary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the primary outcome have been considered. |
12 weeks
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Variation of body weight
Временное ограничение: 12 weeks
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Measure of body weight (kg).
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12 weeks
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Variation of serum inflammatory marker concentration
Временное ограничение: 12 weeks
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Measure of serum IL-2, IL-4, IL-5, IL-6, IL-10, IL-12, IFN-γ,TNF-α, PAI-1, Ghrelin, Leptin, Visfatin, Resistin concentrations (pg/mL). Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered. |
12 weeks
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Variation of blood pressure
Временное ограничение: 12 weeks
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Measure of blood pressure (mmHg). Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered. |
12 weeks
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Variation of body circumferences
Временное ограничение: 12 weeks
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Measure of waist and hip circumferences (mm). Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered. |
12 weeks
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Variation of urine antioxidant marker
Временное ограничение: 12 weeks
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Measurement of betaine in urine (mmol/L). Statistical analysis of the secondary outcome was performed within and between each single intervention-arm. Further, a post-hoc subdivision of the study participants by means of a BMI or glycaemia cut-off value was applied, and statistical differences of the secondary outcome have been considered. |
12 weeks
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Соавторы и исследователи
Спонсор
Соавторы
Следователи
- Главный следователь: Nicoletta Pellegrini, Professor, University of Parma
Публикации и полезные ссылки
Общие публикации
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- Endres JR, Clewell A, Jade KA, Farber T, Hauswirth J, Schauss AG. Safety assessment of a proprietary preparation of a novel Probiotic, Bacillus coagulans, as a food ingredient. Food Chem Toxicol. 2009 Jun;47(6):1231-8. doi: 10.1016/j.fct.2009.02.018. Epub 2009 Feb 25.
- Endres JR, Qureshi I, Farber T, Hauswirth J, Hirka G, Pasics I, Schauss AG. One-year chronic oral toxicity with combined reproduction toxicity study of a novel probiotic, Bacillus coagulans, as a food ingredient. Food Chem Toxicol. 2011 May;49(5):1174-82. doi: 10.1016/j.fct.2011.02.012. Epub 2011 Feb 19.
- Grasten SM, Juntunen KS, Poutanen KS, Gylling HK, Miettinen TA, Mykkanen HM. Rye bread improves bowel function and decreases the concentrations of some compounds that are putative colon cancer risk markers in middle-aged women and men. J Nutr. 2000 Sep;130(9):2215-21. doi: 10.1093/jn/130.9.2215.
- Honda H, Gibson GR, Farmer S, Keller D, McCartney AL. Use of a continuous culture fermentation system to investigate the effect of GanedenBC30 (Bacillus coagulans GBI-30, 6086) supplementation on pathogen survival in the human gut microbiota. Anaerobe. 2011 Feb;17(1):36-42. doi: 10.1016/j.anaerobe.2010.12.006. Epub 2010 Dec 30.
- Hun L. Bacillus coagulans significantly improved abdominal pain and bloating in patients with IBS. Postgrad Med. 2009 Mar;121(2):119-24. doi: 10.3810/pgm.2009.03.1984.
- Kalman DS, Schwartz HI, Alvarez P, Feldman S, Pezzullo JC, Krieger DR. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms. BMC Gastroenterol. 2009 Nov 18;9:85. doi: 10.1186/1471-230X-9-85.
- Katcher HI, Legro RS, Kunselman AR, Gillies PJ, Demers LM, Bagshaw DM, Kris-Etherton PM. The effects of a whole grain-enriched hypocaloric diet on cardiovascular disease risk factors in men and women with metabolic syndrome. Am J Clin Nutr. 2008 Jan;87(1):79-90. doi: 10.1093/ajcn/87.1.79.
- Kimmel M, Keller D, Farmer S, Warrino DE. A controlled clinical trial to evaluate the effect of GanedenBC(30) on immunological markers. Methods Find Exp Clin Pharmacol. 2010 Mar;32(2):129-32. doi: 10.1358/mf.2010.32.2.1423881.
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- Larsson SC, Giovannucci E, Bergkvist L, Wolk A. Whole grain consumption and risk of colorectal cancer: a population-based cohort of 60,000 women. Br J Cancer. 2005 May 9;92(9):1803-7. doi: 10.1038/sj.bjc.6602543.
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- Pellegrini N, Del Rio D, Colombi B, Bianchi M, Brighenti F. Application of the 2,2'-azinobis(3-ethylbenzothiazoline-6-sulfonic acid) radical cation assay to a flow injection system for the evaluation of antioxidant activity of some pure compounds and beverages. J Agric Food Chem. 2003 Jan 1;51(1):260-4. doi: 10.1021/jf020657z.
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Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- SFLAB14
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .