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Trials
Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

The effects of probiotic and synbiotic supplementation on metabolic syndrome indices in adults at risk of type 2 diabetes: study protocol for a randomized controlled trial

Authors: Nazila Kassaian, Ashraf Aminorroaya, Awat Feizi, Parvaneh Jafari, Masoud Amini

Published in: Trials | Issue 1/2017

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Abstract

Background

The incidence of type 2 diabetes, cardiovascular diseases, and obesity has been rising dramatically; however, their pathogenesis is particularly intriguing. Recently, dysbiosis of the intestinal microbiota has emerged as a new candidate that may be linked to metabolic diseases. We hypothesize that selective modulation of the intestinal microbiota by probiotic or synbiotic supplementation may improve metabolic dysfunction and prevent diabetes in prediabetics. In this study, a synthesis and study of synbiotics will be carried out for the first time in Iran.

Methods/Design

In a randomized triple-blind controlled clinical trial, 120 adults with impaired glucose tolerance based on the inclusion criteria will be selected by a simple random sampling method and will be randomly allocated to 6 months of 6 g/d probiotic, synbiotic or placebo. The fecal abundance of bacteria, blood pressure, height, weight, and waist and hip circumferences will be measured at baseline and following treatment. Also, plasma lipid profiles, HbA1C, fasting plasma glucose, and insulin levels, will be measured and insulin resistance (HOMA-IR) and beta-cell function (HOMA-B) will be calculated at baseline and will be repeated at months 3, 6, 12, and 18. The data will be compared within and between groups using statistical methods.

Discussion

The results of this trial could contribute to the evidence-based clinical guidelines that address gut microbiota manipulation to maximize health benefits in prevention and management of metabolic syndrome in prediabetes.

Trial registration

Iranian Registry of Clinical Trials: IRCT201511032321​N2. Registered on 27 February 2016.
Appendix
Available only for authorised users
Literature
1.
Allin KH, Nielsen T, Pedersen O. Mechanisms in endocrinology: gut microbiota in patients with type 2 diabetes mellitus. Eur J Endocrinol. 2015;172(4):R167–R77.CrossRefPubMed
2.
Moslehi J, Libby P. You can’t run from inflammation lower extremity ischemia, hypoxia signaling, and macrophage subtypes. Circ Res. 2012;110(8):1045–6.CrossRefPubMed
3.
Tuttolomondo A, Di Raimondo D, Pecoraro R, Arnao V, Pinto A, Licata G. Atherosclerosis as an inflammatory disease. Curr Pharm Des. 2012;18(28):4266–88.CrossRefPubMed
4.
David LA, Materna AC, Friedman J, Baptista MI, Blackburn MC, Perrotta A, et al. Erratum to: Host lifestyle affects human microbiota on daily timescales. Genome Biol. 2016;17(1):117.CrossRefPubMedPubMedCentral
5.
Fukuda S, Ohno H. Gut microbiome and metabolic diseases. Semin Immunopath. 2014;36(1):103–14.CrossRef
6.
7.
Schwingshackl L, Hoffmann G, Buijsse B, Mittag T, Stelmach-Mardas M, Boeing H, et al. Dietary supplements and risk of cause-specific death, cardiovascular disease, and cancer: a protocol for a systematic review and network meta-analysis of primary prevention trials. Systc Rev. 2015;4(1):34.CrossRef
8.
Larsen N, Vogensen FK, van den Berg FW, Nielsen DS, Andreasen AS, Pedersen BK, et al. Gut microbiota in human adults with type 2 diabetes differs from non-diabetic adults. PLoS One. 2010;5(2), e9085.CrossRefPubMedPubMedCentral
9.
Pussinen PJ, Havulinna AS, Lehto M, Sundvall J, Salomaa V. Endotoxemia is associated with an increased risk of incident diabetes. Diabetes Care. 2011;34(2):392–7.CrossRefPubMedPubMedCentral
10.
Guo X, Xia X, Tang R, Zhou J, Zhao H, Wang K. Development of a real-time PCR method for Firmicutes and Bacteroidetes in faeces and its application to quantify intestinal population of obese and lean pigs. Lett Appl Microbiol. 2008;47(5):367–73.CrossRefPubMed
11.
Zoetendal EG, Vaughan EE, De Vos WM. A microbial world within us. Mol Microbiol. 2006;59(6):1639–50.CrossRefPubMed
12.
Ley RE, Turnbaugh PJ, Klein S, Gordon JI. Microbial ecology: human gut microbes associated with obesity. Nature. 2006;444(7122):1022–3.CrossRefPubMed
13.
Turnbaugh PJ, Ley RE, Mahowald MA, Magrini V, Mardis ER, Gordon JI. An obesity-associated gut microbiome with increased capacity for energy harvest. Nature. 2006;444(7122):1027–131.CrossRefPubMed
14.
Marchesi JR, Adams DH, Fava F, Hermes GD, Hirschfield GM, Hold G, et al. The gut microbiota and host health: a new clinical frontier. Gut. 2016;65(2):330–9.CrossRefPubMed
15.
Ley RE, Bäckhed F, Turnbaugh P, Lozupone CA, Knight RD, Gordon JI. Obesity alters gut microbial ecology. Proc Natl Acad Sci U S A. 2005;102(31):11070–5.CrossRefPubMedPubMedCentral
16.
Macfarlane S, Cleary S, Bahrami B, Reynolds N, Macfarlane G. Synbiotic consumption changes the metabolism and composition of the gut microbiota in older people and modifies inflammatory processes: a randomised, double-blind, placebo-controlled crossover study. Aliment Pharmacol Ther. 2013;38(7):804–16.CrossRefPubMed
17.
Han JL, Lin HL. Intestinal microbiota and type 2 diabetes: from mechanism insights to therapeutic perspective. World J Gastroenterol. 2014;20(47):17737–45.PubMedPubMedCentral
18.
Rastall RA, Gibson GR. Recent developments in prebiotics to selectively impact beneficial microbes and promote intestinal health. Curr Opin Biotechnol. 2015;32:42–6.CrossRefPubMed
19.
Hulston CJ, Churnside AA, Venables MC. Probiotic supplementation prevents high-fat, overfeeding-induced insulin resistance in human subjects. Br J Nutr. 2015;113(4):596–602.CrossRefPubMedPubMedCentral
20.
He C, Shan Y, Song W. Targeting gut microbiota as a possible therapy for diabetes. Nutr Res. 2015;35(5):361–7.CrossRefPubMed
21.
Bang H, Edwards AM, Bomback AS, Ballantyne CM, Brillon D, Callahan MA, et al. Development and validation of a patient self-assessment score for diabetes risk. Ann Intern Med. 2009;151(11):775–83.CrossRefPubMedPubMedCentral
22.
van Zanten GC, Krych L, Röytiö H, Forssten S, Lahtinen SJ, Al-Soud WA, et al. Synbiotic Lactobacillus acidophilus NCFM and cellobiose does not affect human gut bacterial diversity but increases abundance of lactobacilli, bifidobacteria and branched-chain fatty acids: a randomized, double-blinded cross-over trial. FEMS Microbiol Ecol. 2014;90(1):225–36.CrossRefPubMed
23.
Eslamparast T, Zamani F, Hekmatdoost A, Sharafkhah M, Eghtesad S, Malekzadeh R, et al. Effects of synbiotic supplementation on insulin resistance in subjects with the metabolic syndrome: a randomised, double-blind, placebo-controlled pilot study. Br J Nutr. 2014;112(03):438–45.CrossRefPubMed
24.
Pickering TG, Hall JE, Appel LJ, Falkner BE, Graves JW, Hill MN, et al. Recommendations for blood pressure measurement in humans: an AHA scientific statement from the Council on High Blood Pressure Research Professional and Public Education Subcommittee. J Clin Hypertens. 2005;7(2):102–9.CrossRef
25.
Mossavar-Rahmani Y. Reducing measurement error in nutrition assessment: potential research implications for Iran. Nutr Food Sci Res. 2017;4(1):3–10.
26.
Ainsworth BE, Haskell WL, Whitt MC, Irwin ML, Swartz AM, Strath SJ, et al. Compendium of physical activities: an update of activity codes and MET intensities. Med Sci Sports Exerc. 2000;32(9; Suppl):S498–504.CrossRefPubMed
27.
Machin D, Campbell MJ, Tan SB, Tan SH. Sample size tables for clinical studies. Chichester: Wiley; 2011.
28.
Enders CK. A primer on maximum likelihood algorithms available for use with missing data. Struct Equ Model. 2001;8(1):128–41.CrossRef
Metadata
Title
The effects of probiotic and synbiotic supplementation on metabolic syndrome indices in adults at risk of type 2 diabetes: study protocol for a randomized controlled trial
Authors
Nazila Kassaian
Ashraf Aminorroaya
Awat Feizi
Parvaneh Jafari
Masoud Amini
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1885-8

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