Clinical trial NCT06160830: The Effects of Synbiotic on Cardiovascular and Bone Metabolism Markers in Transplanted Kidney Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Transplanted Kidney
Lead sponsor: National Nutrition and Food Technology Institute
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 44
Sex: ALL
Minimum age (years): 16
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Lp (a)
timeFrame: 10 weeks
measure: MDA
timeFrame: 10 weeks
measure: hs-CRP
timeFrame: 10 weeks
measure: sICAM-1
timeFrame: 10 weeks
measure: glucose
timeFrame: 10 weeks
measure: pentosidine
timeFrame: 10 weeks
measure: carboxy-methyl lysine
timeFrame: 10 weeks
measure: Osteoprotegerin
timeFrame: 10 weeks
measure: osteocalcin
timeFrame: 10 weeks
measure: RANKL
timeFrame: 10 weeks
measure: Systolic blood pressure
timeFrame: 10 weeks
measure: Diastolic blood pressure
timeFrame: 10 weeks
measure: N-telopeptide
timeFrame: 10 weeks
measure: triglyceride
timeFrame: 10 weeks
measure: Total cholesterol
timeFrame: 10 weeks
measure: HDL-C
timeFrame: 10 weeks
measure: LDL-C
timeFrame: 10 weeks
measure: the Beck depression test
timeFrame: 10 weeks
measure: The Depression Anxiety Stress Scale
timeFrame: 10 weeks
measure: Weight
timeFrame: 10 weeks
measure: Waist circumference
timeFrame: 10 weeks
measure: Hip circumference
timeFrame: 10 weeks
Secondary outcomes:
measure: albumin
timeFrame: 10 weeks
measure: calcium
timeFrame: 10 weeks
measure: phosphorous
timeFrame: 10 weeks
measure: iPTH
timeFrame: 10 weeks
Other outcomes:
Locations:
Study officials:
References: