The Effects of Synbiotic on Cardiovascular and Bone Metabolism Markers in Transplanted Kidney Patients
- Conditions
- Transplanted Kidney
- Registration Number
- NCT06160830
- Lead Sponsor
- National Nutrition and Food Technology Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 44
- : More than one year has passed since the last kidney transplant
- Having serum creatinine less than 2.5 mg/dL in the last three months
- Being in the age range of 18-75 years
- BMI<35 kg/m2
- Receiving synbiotic supplement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method MDA 10 weeks Serum concentrations of malondialdehyde
Diastolic blood pressure 10 weeks Diastolic blood pressure (mmHg)
Hip circumference 10 weeks Hip circumference
Total cholesterol 10 weeks Serum concentrations of total cholesterol
hs-CRP 10 weeks Serum concentrations of high sensitivity c-reactive protein
pentosidine 10 weeks serum concentration of pentosidine
Lp (a) 10 weeks Serum concentrations of lipoprotein-a
LDL-C 10 weeks Serum concentrations of low-density lipoprotein cholesterol
Waist circumference 10 weeks Waist circumference
RANKL 10 weeks Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
sICAM-1 10 weeks Serum concentrations of Soluble intercellular adhesion molecule-1
glucose 10 weeks serum concentration of fasting glucose
carboxy-methyl lysine 10 weeks serum concentration of carboxy-methyl lysine
N-telopeptide 10 weeks Serum concentrations of N-telopeptide
HDL-C 10 weeks Serum concentrations of High-density lipoprotein cholesterol
Systolic blood pressure 10 weeks Systolic blood pressure (mmHg)
triglyceride 10 weeks Serum concentrations of triglyceride
Osteoprotegerin 10 weeks Serum concentrations of Osteoprotegerin
osteocalcin 10 weeks Serum concentrations of osteocalcin
the Beck depression test 10 weeks Score of the Beck depression test
Weight 10 weeks body Weight in kilograms
The Depression Anxiety Stress Scale 10 weeks Score of Depression Anxiety Stress Scale-(DASS)42
- Secondary Outcome Measures
Name Time Method albumin 10 weeks Serum concentrations of albumin
phosphorous 10 weeks Serum concentrations of phosphorous
calcium 10 weeks Serum concentrations of calcium
iPTH 10 weeks Serum concentrations of Intact parathyroid hormone
Related Research Topics
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