The Effects of Synbiotic on Cardiovascular and Bone Metabolism Markers in Transplanted Kidney Patients

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Synbiotic Supplement on Anthropometric Parameters, Cardiovascular Disease Risk Factors, and Bone Metabolism Markers in Transplanted Kidney Patients on Chronic Post-kidney Transplant Phase Diet

Conditions
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Transplanted Kidney

Intervention / Treatment
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* Dietary Supplement: synbiotic
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: : 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 Exclusion Criteria: Receiving synbiotic supplement

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: synbiotic<br>Patients in the synbiotic group will receive, for 10-12 weeks, Two capsules of synbiotic (Zist Takhmir Company) per day, each containing 500 mg of synbiotic. Patients in this group received a multispecies probiotic product (109 CFU/capsule) and fructo oligosaccharid as prebiotics. | Dietary Supplement: synbiotic<br>* Two capsules of synbiotic per day, each containing 500 mg of synbiotic<br>|
| Placebo Comparator: placebo<br>Patients in the placebo group will receive Two capsules of placebo containing maltodextrin per day. The placebo powder will comparable in color, texture, and taste to the synbiotics. Supplement packaging will be done by Zist Takhmir Company. | Other: placebo<br>* Two capsules of placebo containing maltodextrin per day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lp (a) | Serum concentrations of lipoprotein-a | 10 weeks | 
| MDA | Serum concentrations of malondialdehyde | 10 weeks | 
| hs-CRP | Serum concentrations of high sensitivity c-reactive protein | 10 weeks | 
| sICAM-1 | Serum concentrations of Soluble intercellular adhesion molecule-1 | 10 weeks | 
| glucose | serum concentration of fasting glucose | 10 weeks | 
| pentosidine | serum concentration of pentosidine | 10 weeks | 
| carboxy-methyl lysine | serum concentration of carboxy-methyl lysine | 10 weeks | 
| Osteoprotegerin | Serum concentrations of Osteoprotegerin | 10 weeks | 
| osteocalcin | Serum concentrations of osteocalcin | 10 weeks | 
| RANKL | Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand | 10 weeks | 
| Systolic blood pressure | Systolic blood pressure (mmHg) | 10 weeks | 
| Diastolic blood pressure | Diastolic blood pressure (mmHg) | 10 weeks | 
| N-telopeptide | Serum concentrations of N-telopeptide | 10 weeks | 
| triglyceride | Serum concentrations of triglyceride | 10 weeks | 
| Total cholesterol | Serum concentrations of total cholesterol | 10 weeks | 
| HDL-C | Serum concentrations of High-density lipoprotein cholesterol | 10 weeks | 
| LDL-C | Serum concentrations of low-density lipoprotein cholesterol | 10 weeks | 
| the Beck depression test | Score of the Beck depression test | 10 weeks | 
| The Depression Anxiety Stress Scale | Score of Depression Anxiety Stress Scale-(DASS)42 | 10 weeks | 
| Weight | body Weight in kilograms | 10 weeks | 
| Waist circumference | Waist circumference | 10 weeks | 
| Hip circumference | Hip circumference | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| albumin | Serum concentrations of albumin | 10 weeks | 
| calcium | Serum concentrations of calcium | 10 weeks | 
| phosphorous | Serum concentrations of phosphorous | 10 weeks | 
| iPTH | Serum concentrations of Intact parathyroid hormone | 10 weeks |