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

Not Applicable

Not yet recruiting

• Conditions: Transplanted Kidney
• Interventions: Dietary Supplement: synbiotic; Other: placebo

• 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

Study Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-29
• Study First Submitted QC: 2023-11-29
• Last Update Submitted: 2023-11-29
• Study Start: 2023-12-01
• Study First Posted: 2023-12-07
• Last Update Posted: 2023-12-07
• Primary Completion: 2024-04-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
synbiotic	synbiotic	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.
placebo	placebo	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.

Primary Outcome Measures

Name	Time	Method
Total cholesterol	10 weeks	Serum concentrations of total cholesterol
MDA	10 weeks	Serum concentrations of malondialdehyde
Weight	10 weeks	body Weight in kilograms
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
Diastolic blood pressure	10 weeks	Diastolic blood pressure (mmHg)
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
The Depression Anxiety Stress Scale	10 weeks	Score of Depression Anxiety Stress Scale-(DASS)42
Hip circumference	10 weeks	Hip circumference

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