Clinical trial NCT02236533: Healthy Effects of an Innovative Probiotic Pasta
Official title: Healthy Effects of an Innovative Probiotic Pasta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: OBESITY
INFLAMMATION
DYSLIPIDEMIA
CONSTIPATION
Lead sponsor: University of Parma
Sponsor class: OTHER
Collaborators: name: Universita di Verona
First posted: 2014-09-10
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of the project was the evaluation of the antioxidant and anti-inflammatory effects of a whole grain pasta, enriched in barley β-glucans and fortified with strains of Bacillus coagulans, versus a control wheat pasta on healthy volunteers, using a parallel randomized controlled trial.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Variation of plasma lipids
timeFrame: 12 weeks
measure: Variation of fecal microbiota composition
timeFrame: 12 weeks
measure: Variation of antioxidant activity on fecal waters
timeFrame: 12 weeks
Secondary outcomes:
measure: Variation of body weight
timeFrame: 12 weeks
measure: Variation of serum inflammatory marker concentration
timeFrame: 12 weeks
measure: Variation of blood pressure
timeFrame: 12 weeks
measure: Variation of body circumferences
timeFrame: 12 weeks
measure: Variation of urine antioxidant marker
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Parma
country: Italy
facility: University of Parma - Department of Food Sciences
state: PR
city: Parma
country: Italy
facility: University of Parma
Study officials:
affiliation: University of Parma
name: Nicoletta Pellegrini, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersson A, Tengblad S, Karlstrom B, Kamal-Eldin A, Landberg R, Basu S, Aman P, Vessby B. Whole-grain foods do not affect insulin sensitivity or markers of lipid peroxidation and inflammation in healthy, moderately overweight subjects. J Nutr. 2007 Jun;137(6):1401-7. doi: 10.1093/jn/137.6.1401.
citation: Behall KM, Scholfield DJ, Hallfrisch J. Diets containing barley significantly reduce lipids in mildly hypercholesterolemic men and women. Am J Clin Nutr. 2004 Nov;80(5):1185-93. doi: 10.1093/ajcn/80.5.1185.
citation: Behall KM, Scholfield DJ, Hallfrisch J. Whole-grain diets reduce blood pressure in mildly hypercholesterolemic men and women. J Am Diet Assoc. 2006 Sep;106(9):1445-9. doi: 10.1016/j.jada.2006.06.010.
citation: Bird AR, Vuaran MS, King RA, Noakes M, Keogh J, Morell MK, Topping DL. Wholegrain foods made from a novel high-amylose barley variety (Himalaya 292) improve indices of bowel health in human subjects. Br J Nutr. 2008 May;99(5):1032-40. doi: 10.1017/S000711450783902X. Epub 2007 Oct 8.
citation: Brouns F, Hemery Y, Price R, Anson NM. Wheat aleurone: separation, composition, health aspects, and potential food use. Crit Rev Food Sci Nutr. 2012;52(6):553-68. doi: 10.1080/10408398.2011.589540.
citation: Brownlee IA, Moore C, Chatfield M, Richardson DP, Ashby P, Kuznesof SA, Jebb SA, Seal CJ. Markers of cardiovascular risk are not changed by increased whole-grain intake: the WHOLEheart study, a randomised, controlled dietary intervention. Br J Nutr. 2010 Jul;104(1):125-34. doi: 10.1017/S0007114510000644. Epub 2010 Mar 23.
citation: Costabile A, Klinder A, Fava F, Napolitano A, Fogliano V, Leonard C, Gibson GR, Tuohy KM. Whole-grain wheat breakfast cereal has a prebiotic effect on the human gut microbiota: a double-blind, placebo-controlled, crossover study. Br J Nutr. 2008 Jan;99(1):110-20. doi: 10.1017/S0007114507793923. Epub 2007 Aug 29.
citation: de Munter JS, Hu FB, Spiegelman D, Franz M, van Dam RM. Whole grain, bran, and germ intake and risk of type 2 diabetes: a prospective cohort study and systematic review. PLoS Med. 2007 Aug;4(8):e261. doi: 10.1371/journal.pmed.0040261.
citation: Dolin BJ. Effects of a proprietary Bacillus coagulans preparation on symptoms of diarrhea-predominant irritable bowel syndrome. Methods Find Exp Clin Pharmacol. 2009 Dec;31(10):655-9. doi: 10.1358/mf.2009.31.10.1441078.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Lappi J, Kolehmainen M, Mykkanen H, Poutanen K. Do large intestinal events explain the protective effects of whole grain foods against type 2 diabetes? Crit Rev Food Sci Nutr. 2013;53(6):631-40. doi: 10.1080/10408398.2010.550388.
citation: Lappi J, Salojarvi J, Kolehmainen M, Mykkanen H, Poutanen K, de Vos WM, Salonen A. Intake of whole-grain and fiber-rich rye bread versus refined wheat bread does not differentiate intestinal microbiota composition in Finnish adults with metabolic syndrome. J Nutr. 2013 May;143(5):648-55. doi: 10.3945/jn.112.172668. Epub 2013 Mar 20.
citation: 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.
citation: Leinonen KS, Poutanen KS, Mykkanen HM. Rye bread decreases serum total and LDL cholesterol in men with moderately elevated serum cholesterol. J Nutr. 2000 Feb;130(2):164-70. doi: 10.1093/jn/130.2.164.
citation: Mandel DR, Eichas K, Holmes J. Bacillus coagulans: a viable adjunct therapy for relieving symptoms of rheumatoid arthritis according to a randomized, controlled trial. BMC Complement Altern Med. 2010 Jan 12;10:1. doi: 10.1186/1472-6882-10-1.
citation: Martinez I, Lattimer JM, Hubach KL, Case JA, Yang J, Weber CG, Louk JA, Rose DJ, Kyureghian G, Peterson DA, Haub MD, Walter J. Gut microbiome composition is linked to whole grain-induced immunological improvements. ISME J. 2013 Feb;7(2):269-80. doi: 10.1038/ismej.2012.104. Epub 2012 Oct 4.
citation: McIntosh GH, Noakes M, Royle PJ, Foster PR. Whole-grain rye and wheat foods and markers of bowel health in overweight middle-aged men. Am J Clin Nutr. 2003 Apr;77(4):967-74. doi: 10.1093/ajcn/77.4.967.
citation: Mellen PB, Walsh TF, Herrington DM. Whole grain intake and cardiovascular disease: a meta-analysis. Nutr Metab Cardiovasc Dis. 2008 May;18(4):283-90. doi: 10.1016/j.numecd.2006.12.008. Epub 2007 Apr 20.
citation: Nilsson AC, Ostman EM, Holst JJ, Bjorck IM. Including indigestible carbohydrates in the evening meal of healthy subjects improves glucose tolerance, lowers inflammatory markers, and increases satiety after a subsequent standardized breakfast. J Nutr. 2008 Apr;138(4):732-9. doi: 10.1093/jn/138.4.732.
citation: 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.
citation: Pereira MA, Jacobs DR Jr, Pins JJ, Raatz SK, Gross MD, Slavin JL, Seaquist ER. Effect of whole grains on insulin sensitivity in overweight hyperinsulinemic adults. Am J Clin Nutr. 2002 May;75(5):848-55. doi: 10.1093/ajcn/75.5.848.
citation: Priebe MG, Wang H, Weening D, Schepers M, Preston T, Vonk RJ. Factors related to colonic fermentation of nondigestible carbohydrates of a previous evening meal increase tissue glucose uptake and moderate glucose-associated inflammation. Am J Clin Nutr. 2010 Jan;91(1):90-7. doi: 10.3945/ajcn.2009.28521. Epub 2009 Nov 4.
citation: Ross AB, Bruce SJ, Blondel-Lubrano A, Oguey-Araymon S, Beaumont M, Bourgeois A, Nielsen-Moennoz C, Vigo M, Fay LB, Kochhar S, Bibiloni R, Pittet AC, Emady-Azar S, Grathwohl D, Rezzi S. A whole-grain cereal-rich diet increases plasma betaine, and tends to decrease total and LDL-cholesterol compared with a refined-grain diet in healthy subjects. Br J Nutr. 2011 May;105(10):1492-502. doi: 10.1017/S0007114510005209. Epub 2011 Jan 28.
citation: Sahyoun NR, Jacques PF, Zhang XL, Juan W, McKeown NM. Whole-grain intake is inversely associated with the metabolic syndrome and mortality in older adults. Am J Clin Nutr. 2006 Jan;83(1):124-31. doi: 10.1093/ajcn/83.1.124.
citation: Scazzina F, Siebenhandl-Ehn S, Pellegrini N. The effect of dietary fibre on reducing the glycaemic index of bread. Br J Nutr. 2013 Apr 14;109(7):1163-74. doi: 10.1017/S0007114513000032. Epub 2013 Feb 18.
citation: Emerick RE. The politics of psychiatric self-help: political factions, interactional support, and group longevity in a social movement. Soc Sci Med. 1991;32(10):1121-8. doi: 10.1016/0277-9536(91)90088-t.
citation: Valtuena S, Pellegrini N, Franzini L, Bianchi MA, Ardigo D, Del Rio D, Piatti P, Scazzina F, Zavaroni I, Brighenti F. Food selection based on total antioxidant capacity can modify antioxidant intake, systemic inflammation, and liver function without altering markers of oxidative stress. Am J Clin Nutr. 2008 May;87(5):1290-7. doi: 10.1093/ajcn/87.5.1290.
citation: Whelton SP, Hyre AD, Pedersen B, Yi Y, Whelton PK, He J. Effect of dietary fiber intake on blood pressure: a meta-analysis of randomized, controlled clinical trials. J Hypertens. 2005 Mar;23(3):475-81. doi: 10.1097/01.hjh.0000160199.51158.cf.
citation: Ye EQ, Chacko SA, Chou EL, Kugizaki M, Liu S. Greater whole-grain intake is associated with lower risk of type 2 diabetes, cardiovascular disease, and weight gain. J Nutr. 2012 Jul;142(7):1304-13. doi: 10.3945/jn.111.155325. Epub 2012 May 30.
citation: Angelino D, Martina A, Rosi A, Veronesi L, Antonini M, Mennella I, Vitaglione P, Grioni S, Brighenti F, Zavaroni I, Fares C, Torriani S, Pellegrini N. Glucose- and Lipid-Related Biomarkers Are Affected in Healthy Obese or Hyperglycemic Adults Consuming a Whole-Grain Pasta Enriched in Prebiotics and Probiotics: A 12-Week Randomized Controlled Trial. J Nutr. 2019 Oct 1;149(10):1714-1723. doi: 10.1093/jn/nxz071.