Healthy Effects of an Innovative Probiotic Pasta

NCT02236533 | Completed DMC

• 1 other identifier: SFLAB14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

OBESITY; INFLAMMATION; DYSLIPIDEMIA; CONSTIPATION

Outcome Measures

Primary Outcomes (3)

• Variation of plasma lipids

  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

• Variation of fecal microbiota composition

  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

• Variation of antioxidant activity on fecal waters

  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

Secondary Outcomes (5)

• Variation of body weight

  12 weeks

• Variation of serum inflammatory marker concentration

  12 weeks

• Variation of blood pressure

  12 weeks

• Variation of body circumferences

  12 weeks

• Variation of urine antioxidant marker

  12 weeks

Study Arms (2)

Control pasta

PLACEBO COMPARATOR

Volunteers were fed with control pasta, without B-glucans and spores of B. coagulans once a day for 12 weeks.

Dietary Supplement: whole grain pasta

Probiotic Whole Grain Pasta

EXPERIMENTAL

Volunteers were fed with probiotic fortified pasta, including B-glucans and spores of B. coagulans once a day for 12 weeks.

Dietary Supplement: whole grain pasta

Interventions

whole grain pasta DIETARY_SUPPLEMENT

Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.

Control pasta; Probiotic Whole Grain Pasta

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Overweight / Obesity
• Lower consumers of fruit and vegetables

You may not qualify if:

• Antibiotic treatment within 3 months prior the pasta feeding
• Chronic diseases
• Surgeries
• Consumer of whole grain products
• Dieting
• Pregnant or lactating

Sponsors & Collaborators

• University of Parma: lead
• Universita di Verona: collaborator

Study Sites (2)

University of Parma - Department of Food Sciences

Parma, PR, 43124, Italy

Location

University of Parma

Parma, 43124, Italy

Location

Related Publications (37)

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  PMID: 17513398 BACKGROUND

• 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.

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  PMID: 16963350 BACKGROUND

• 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.

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• 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.

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• 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.

  PMID: 17761020 BACKGROUND

• 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.

  PMID: 17760498 BACKGROUND

• 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.

  PMID: 20140275 BACKGROUND

• 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.

  PMID: 19248815 BACKGROUND

• 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.

  PMID: 21338652 BACKGROUND

• 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.

  PMID: 10958815 BACKGROUND

• 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.

  PMID: 21195203 BACKGROUND

• 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.

  PMID: 19332970 BACKGROUND

• 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.

  PMID: 19922649 BACKGROUND

• 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.

  PMID: 18175740 BACKGROUND

• 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.

  PMID: 20401350 BACKGROUND

• 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.

  PMID: 23627504 BACKGROUND

• 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.

  PMID: 23514765 BACKGROUND

• 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.

  PMID: 15827552 BACKGROUND

• 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.

  PMID: 10720164 BACKGROUND

• 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.

  PMID: 20067641 BACKGROUND

• 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.

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• 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.

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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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• 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.

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• 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.

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• 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.

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• 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.

  PMID: 31162597 DERIVED

MeSH Terms

Conditions

Obesity; Inflammation; Dyslipidemias; Constipation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes; Lipid Metabolism Disorders; Metabolic Diseases; Signs and Symptoms, Digestive

Study Officials

• Nicoletta Pellegrini, Professor

  University of Parma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 26, 2014
• First Posted: September 10, 2014
• Study Start: March 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: March 1, 2015
• Last Updated: November 1, 2018

Record last verified: 2018-10

Locations

IT (2)