Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trial

Introduction To alleviate clinical symptoms of diabetic nephropathy (DN), several dietary and non-dietary strategies have been suggested. Probiotic-enriched foods, through their effects on modulating microflora, might help these patients control the adverse effects. The current study will be done to...

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Main Authors: Alireza Esteghamati, Ahmad Esmaillzadeh, Seyed Mojtaba Ghoreishy, Nooshin Shirzad, Manouchehr Nakhjavani, Kurosh Djafarian
Format: Article
Language:English
Published: BMJ Publishing Group 2022-03-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/12/3/e056110.full
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author Alireza Esteghamati
Ahmad Esmaillzadeh
Seyed Mojtaba Ghoreishy
Nooshin Shirzad
Manouchehr Nakhjavani
Kurosh Djafarian
author_facet Alireza Esteghamati
Ahmad Esmaillzadeh
Seyed Mojtaba Ghoreishy
Nooshin Shirzad
Manouchehr Nakhjavani
Kurosh Djafarian
author_sort Alireza Esteghamati
collection DOAJ
description Introduction To alleviate clinical symptoms of diabetic nephropathy (DN), several dietary and non-dietary strategies have been suggested. Probiotic-enriched foods, through their effects on modulating microflora, might help these patients control the adverse effects. The current study will be done to examine the effects of probiotic yoghurt consumption on albumin to creatinine ratio, estimated glomerular filtration rate (eGFR) and metabolic parameters in patients with type 2 diabetes with nephropathy.Methods and analysis Sixty patients with DN will be recruited in this study. After block matching for sex, body mass index and age, patients will be randomly assigned to receive 300 g/day probiotic yoghurt containing 106 CFU/g Lactobacillus acidophilus and Bifidobacterium lactis strains or 300 g/day plain yoghurt daily for 8 weeks. Weight, height and waist circumference will be measured at study baseline and after the intervention. Biochemical indicators including glycaemic measures (haemoglobin A1c (HbA1c), fasting blood sugar (FBS)), inflammatory markers (high sensitivity-C reactive protein), lipid profile (total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL)) and finally renal makers (creatinine, albumin to creatinine ratio, eGFR) will be assessed at study baseline and at the end of the trial.Discussion Improving the condition of a person with DN is a serious clinical challenge. The use of probiotic supplements has been considered in these people, but the use of probiotic-enriched foods has received less attention.Trial registration number Iranian Registry of Clinical Trials (www.irct.ir) (IRCT20201125049491N1).
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spelling doaj-art-4c325561e3fb48e98acdea2feca76dcf2025-08-20T01:48:10ZengBMJ Publishing GroupBMJ Open2044-60552022-03-0112310.1136/bmjopen-2021-056110Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trialAlireza Esteghamati0Ahmad Esmaillzadeh1Seyed Mojtaba Ghoreishy2Nooshin Shirzad3Manouchehr Nakhjavani4Kurosh Djafarian5Endocrinology and Metabolism Research Center, Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, IranDepartment of Community Nutrition, Tehran University of Medical Sciences, Tehran, IranDepartment of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, IranEndocrinology and Metabolism Research Center, Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, IranEndocrinology and Metabolism Research Center, Vali-Asr Hospital, School of Medicine, Tehran University of Medical Sciences, Tehran, IranDepartment of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, IranIntroduction To alleviate clinical symptoms of diabetic nephropathy (DN), several dietary and non-dietary strategies have been suggested. Probiotic-enriched foods, through their effects on modulating microflora, might help these patients control the adverse effects. The current study will be done to examine the effects of probiotic yoghurt consumption on albumin to creatinine ratio, estimated glomerular filtration rate (eGFR) and metabolic parameters in patients with type 2 diabetes with nephropathy.Methods and analysis Sixty patients with DN will be recruited in this study. After block matching for sex, body mass index and age, patients will be randomly assigned to receive 300 g/day probiotic yoghurt containing 106 CFU/g Lactobacillus acidophilus and Bifidobacterium lactis strains or 300 g/day plain yoghurt daily for 8 weeks. Weight, height and waist circumference will be measured at study baseline and after the intervention. Biochemical indicators including glycaemic measures (haemoglobin A1c (HbA1c), fasting blood sugar (FBS)), inflammatory markers (high sensitivity-C reactive protein), lipid profile (total cholesterol (TC), triglyceride (TG), low-density lipoprotein (LDL), high-density lipoprotein (HDL)) and finally renal makers (creatinine, albumin to creatinine ratio, eGFR) will be assessed at study baseline and at the end of the trial.Discussion Improving the condition of a person with DN is a serious clinical challenge. The use of probiotic supplements has been considered in these people, but the use of probiotic-enriched foods has received less attention.Trial registration number Iranian Registry of Clinical Trials (www.irct.ir) (IRCT20201125049491N1).https://bmjopen.bmj.com/content/12/3/e056110.full
spellingShingle Alireza Esteghamati
Ahmad Esmaillzadeh
Seyed Mojtaba Ghoreishy
Nooshin Shirzad
Manouchehr Nakhjavani
Kurosh Djafarian
Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trial
BMJ Open
title Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trial
title_full Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trial
title_fullStr Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trial
title_full_unstemmed Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trial
title_short Effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio, eGFR and metabolic parameters in patients with type 2 diabetes with microalbuminuria: study protocol for a randomised controlled clinical trial
title_sort effect of daily consumption of probiotic yoghurt on albumin to creatinine ratio egfr and metabolic parameters in patients with type 2 diabetes with microalbuminuria study protocol for a randomised controlled clinical trial
url https://bmjopen.bmj.com/content/12/3/e056110.full
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