Transplanted Kidney
Conditions
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.
Interventions
DIETARY_SUPPLEMENTsynbiotic
Two capsules of synbiotic per day, each containing 500 mg of synbiotic
OTHERplacebo
Two capsules of placebo containing maltodextrin per day
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
16 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hip circumference | 10 weeks | Hip circumference |
| HDL-C | 10 weeks | Serum concentrations of High-density lipoprotein cholesterol |
| LDL-C | 10 weeks | Serum concentrations of low-density lipoprotein cholesterol |
| the Beck depression test | 10 weeks | Score of the Beck depression test |
| Waist circumference | 10 weeks | Waist circumference |
| The Depression Anxiety Stress Scale | 10 weeks | Score of Depression Anxiety Stress Scale-(DASS)42 |
| Weight | 10 weeks | body Weight in kilograms |
| Lp (a) | 10 weeks | Serum concentrations of lipoprotein-a |
| MDA | 10 weeks | Serum concentrations of malondialdehyde |
| hs-CRP | 10 weeks | Serum concentrations of high sensitivity c-reactive protein |
| sICAM-1 | 10 weeks | Serum concentrations of Soluble intercellular adhesion molecule-1 |
| glucose | 10 weeks | serum concentration of fasting glucose |
| pentosidine | 10 weeks | serum concentration of pentosidine |
| carboxy-methyl lysine | 10 weeks | serum concentration of carboxy-methyl lysine |
| Osteoprotegerin | 10 weeks | Serum concentrations of Osteoprotegerin |
| osteocalcin | 10 weeks | Serum concentrations of osteocalcin |
| RANKL | 10 weeks | Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand |
| Systolic blood pressure | 10 weeks | Systolic blood pressure (mmHg) |
| Diastolic blood pressure | 10 weeks | Diastolic blood pressure (mmHg) |
| N-telopeptide | 10 weeks | Serum concentrations of N-telopeptide |
| triglyceride | 10 weeks | Serum concentrations of triglyceride |
| Total cholesterol | 10 weeks | Serum concentrations of total cholesterol |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| albumin | 10 weeks | Serum concentrations of albumin |
| calcium | 10 weeks | Serum concentrations of calcium |
| phosphorous | 10 weeks | Serum concentrations of phosphorous |
| iPTH | 10 weeks | Serum concentrations of Intact parathyroid hormone |
Contacts
Primary Contactzahra yari, PhD
Outcome results
None listed