Effect of diet restricted in advanced glycation end products (low-AGEs) on vascular adhesion, inflammatory markers, vascular vasodilation (FMD), energy expenditure and brown adipose tissue activity in patients treated with angioplasty

The aim of this study is to determine the effect of diet restricted in advanced glycation end products (low-AGEs) on vascular adhesion, inflammatory markers, vascular vasodilation (Flow Mediated Dilation), energy expenditure and brown adipose tissue activity in patients treated with angioplasty.

The present study is a parallel randomized clinical trial with a control group.

Patients are randomly divided into two groups of 40: intervention and control. Food record questionnaire to measure and control macronutrients and AGEs intake in the diet and physical activity registration to measure energy expenditure and adjustment of physical activity effect on AGEs production in body will be evaluated in beginning and every two weeks during the study. Ten milliliter fasting blood will be taken from all patients at the beginning and end of the intervention.

Patients aged 50 to 70 years whose BMI is between 18.5 to 35 kg/m2 and are required to undergo angioplasty due to obstruction in one or two vessels, will be enrolled. Patients with a history of diabetes, chronic kidney and liver diseases, autoimmune diseases and cancer, consumed multivitamin-mineral supplements over the past 3 months, followed any weight loss or other special diets during last year, or smoke won't be entered in study.

To the intervention group, the low-AGEs diet, and to the control group, the cardiovascular diet based on general recommendations provided by AHA with focusing on the reduction of saturated fats and salt will be given. Both groups will be required to follow their diet for 12 weeks.

The amount of energy expenditure and vascular vasodilatation (FMD) and serum levels of IL-6, TNF-α, VCAM, hs-CRP, MDA, NRG4, FGF21 and carboxy methyl lysine will be measured in both groups before and After the intervention.

Since two variables of gender and BMI affect the outcomes of the study, and the two groups must be similar in terms of these two variables, randomization is done using stratified randomization based on these two variables. Combining the two variables of gender and BMI causes six classes: a man with a BMI less than 25, a man with a BMI of 25 to 30, a man with a BMI higher than 30, a woman with a BMI less than 25, a woman with a BMI of 25 to 30, and a woman with a BMI higher than 30. Then for each of these categories, random binary blocks are determined using table of random numbers. Eligible individuals entered the study, are placed in their own class according to their gender and BMI and based on the randomized sequences defined for that class, are assigned to either of the two groups receiving low-AGEs diet or cardiovascular diet (on basis of AHA recommendations). Given that the intervention of this study is diet and the person who enters the patients in the study and describes the type of diet for each patient, cannot be blind to the type of diet that each patient receives, allocation concealment does not apply in this study.