The aim of this double-blind randomized clinical trial is to determine the effects of synbiotic supplement on cardiovascular disease risk factors and bone metabolism markers and depression, in transplanted kidney patients on chronic post-kidney transplant phase diet.This study is a double-blind, randomized controlled clinical trial with two parallel groups. 44 patients will be randomly assigned into synbiotic and control group. Transplanted kidney patients referring to the hospital clinics will be invited to participate. After assessing the entrance criteria, 7 cc blood samples are taken. The food recall is completed. Supplements are given to patients for 10-12 weeks. Serum concentrations of malondialdehyde; high sensitivity c-reactive protein; Soluble intercellular adhesion molecule-1; glucose; pentosidine; carboxy-methyl lysine; osteoprotegerin; Receptor activator of nuclear factor kappa-Β ligand; N-telopeptide; Intact parathyroid hormone; triglyceride; total cholesterol; High-density lipoprotein cholesterol; low-density lipoprotein cholesterol; lipoprotein-a; albumin; calcium; phosphorous; blood nitrogen urea; creatinine; and also systolic blood pressure; diastolic blood pressure; Weight; Body mass index; Waist circumference; Hip circumference; and questionnaires including quality of depression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Lp (a)
Serum concentrations of lipoprotein-a
Time frame: 10 weeks
MDA
Serum concentrations of malondialdehyde
Time frame: 10 weeks
hs-CRP
Serum concentrations of high sensitivity c-reactive protein
Time frame: 10 weeks
sICAM-1
Serum concentrations of Soluble intercellular adhesion molecule-1
Time frame: 10 weeks
glucose
serum concentration of fasting glucose
Time frame: 10 weeks
pentosidine
serum concentration of pentosidine
Time frame: 10 weeks
carboxy-methyl lysine
serum concentration of carboxy-methyl lysine
Time frame: 10 weeks
Osteoprotegerin
Serum concentrations of Osteoprotegerin
Time frame: 10 weeks
osteocalcin
Serum concentrations of osteocalcin
Time frame: 10 weeks
RANKL
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Time frame: 10 weeks
Systolic blood pressure
Systolic blood pressure (mmHg)
Time frame: 10 weeks
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Time frame: 10 weeks
N-telopeptide
Serum concentrations of N-telopeptide
Time frame: 10 weeks
triglyceride
Serum concentrations of triglyceride
Time frame: 10 weeks
Total cholesterol
Serum concentrations of total cholesterol
Time frame: 10 weeks
HDL-C
Serum concentrations of High-density lipoprotein cholesterol
Time frame: 10 weeks
LDL-C
Serum concentrations of low-density lipoprotein cholesterol
Time frame: 10 weeks
the Beck depression test
Score of the Beck depression test
Time frame: 10 weeks
The Depression Anxiety Stress Scale
Score of Depression Anxiety Stress Scale-(DASS)42
Time frame: 10 weeks
Weight
body Weight in kilograms
Time frame: 10 weeks
Waist circumference
Waist circumference
Time frame: 10 weeks
Hip circumference
Hip circumference
Time frame: 10 weeks
albumin
Serum concentrations of albumin
Time frame: 10 weeks
calcium
Serum concentrations of calcium
Time frame: 10 weeks
phosphorous
Serum concentrations of phosphorous
Time frame: 10 weeks
iPTH
Serum concentrations of Intact parathyroid hormone
Time frame: 10 weeks
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