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

NCT06160830 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2023-12-07

No results posted yet for this study

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.

Conditions

  • Transplanted Kidney

Interventions

DIETARY_SUPPLEMENT

synbiotic

Two capsules of synbiotic per day, each containing 500 mg of synbiotic

OTHER

placebo

Two capsules of placebo containing maltodextrin per day

Sponsors & Collaborators

  • National Nutrition and Food Technology Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2024-04-01
Completion
2024-05-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06160830 on ClinicalTrials.gov