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

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

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 Overview

• Status: Not yet recruiting
• Conditions: Transplanted Kidney
• Intervention / Treatment: Dietary supplement: synbiotic; Other: placebo

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: zahra yari, PhD; Phone Number: +982122357484; Email: zahrayari_nut@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Dietary supplement: synbiotic; Two capsules of synbiotic per day, each containing 500 mg of synbiotic
Placebo Comparator: 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.	Other: placebo; Two capsules of placebo containing maltodextrin per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Waist circumference	Waist circumference	10 weeks
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
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
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
osteocalcin	Serum concentrations of osteocalcin	10 weeks
N-telopeptide	Serum concentrations of N-telopeptide	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
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

Collaborators and Investigators

• Sponsor: National Nutrition and Food Technology Institute

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): May 1, 2024

Study Registration Dates

• First Submitted: November 29, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Estimated): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 051

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No