Effects of traditional fermented food (Ash-Kardeh) consumption on blood glucose, blood pressure, and lipid profile in ty

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STUDY PROTOCOL

Effects of traditional fermented food (Ash-Kardeh) consumption on blood glucose, blood pressure, and lipid profile in type 2 diabetes: a study protocol for a randomized clinical trial Hossein Imani 1 & Sayed Omid Salehi 1,2 & Farzad Karimpour 3

&

Mohammadreza Jowshan 4 & Farzad Portavan 4

Received: 4 July 2020 / Accepted: 8 September 2020 # Springer Nature Switzerland AG 2020

Abstract Background Many therapeutic methods are recommended for the management of Type 2 diabetes. Ash-Kardeh contains several components such as flavonoids, antioxidants, and dietary fiber which can affect lipid profile and blood pressure in diabetic patients. However, no study has examined the effects of Ash-Kardeh consumption on blood glucose, blood pressure, and lipid profile in type 2 diabetic patients; therefore, the aim of this study will be to examine the effects of Ash-Kardeh consumption on blood glucose, blood pressure, and lipid profile in type 2 diabetic patients. Methods This study is a randomized, no-blinded, controlled clinical trial in which 44 type 2 diabetic patients will be randomly allocated to intervention and control groups. Individuals in both the intervention and control groups will receive (the usual treatment of diabetic patients) for 6 weeks, while those in the intervention group will receive (250 g of traditional fermented food daily in addition to the usual treatment) at the same time. Assessment of anthropometric measures, blood pressure, and biochemical parameters including serum concentrations of fasting blood sugar, high-density lipoproteins-cholesterol, low-density lipoproteins-cholesterol, total cholesterol, and triglyceride will be performed at the study baseline and end of the trial. Keywords Type 2 diabetes . Hypertension . Dyslipidemias . Fermented food

Abbreviations A-K Ash-Kardeh BMI Body mass index FBS Fasting Blood Sugar HDL-C High-density lipoproteins-cholesterol LDL-C Low-density lipoproteins-cholesterol T2D Type 2 Diabetes

TC TG

Total cholesterol Triglyceride

Trial registration This clinical study was registered on the https://fa.irct. ir website (shortened name ETFFT2D; registration number IRCT20170202032367N3). * Farzad Karimpour [email protected] Hossein Imani [email protected] Sayed Omid Salehi [email protected] Mohammadreza Jowshan [email protected] Farzad Portavan [email protected]

1

Department of Clinical Nutrition, School of Nutritional Sciences and Dietetics, Tehran University of Medical Sciences, Tehran, Iran

2

Students’ Scientific Research Center, Tehran University of Medical Sciences, Tehran, Iran

3

Social Determinants of Health Research Center, Yasuj University of Medical Science, Yasuj, Iran

4

Students Research Committee, Yasuj University of Medical Sciences, Yasuj, Iran

J Diabetes Metab Disord

Background Diabetes is among the most common chronic metabolic disorders, sometimes referred to as the “silent epidemic”, and is a major global health problem, with numerous and dangerous side effects such as atherosclerosis,