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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 44
- 主要终点
- Total cholesterol
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 16 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •: 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
排除标准
- •Receiving synbiotic supplement
结局指标
主要结局
Total cholesterol
时间窗: 10 weeks
Serum concentrations of total cholesterol
hs-CRP
时间窗: 10 weeks
Serum concentrations of high sensitivity c-reactive protein
pentosidine
时间窗: 10 weeks
serum concentration of pentosidine
Lp (a)
时间窗: 10 weeks
Serum concentrations of lipoprotein-a
MDA
时间窗: 10 weeks
Serum concentrations of malondialdehyde
Diastolic blood pressure
时间窗: 10 weeks
Diastolic blood pressure (mmHg)
LDL-C
时间窗: 10 weeks
Serum concentrations of low-density lipoprotein cholesterol
Waist circumference
时间窗: 10 weeks
Waist circumference
RANKL
时间窗: 10 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
sICAM-1
时间窗: 10 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
glucose
时间窗: 10 weeks
serum concentration of fasting glucose
carboxy-methyl lysine
时间窗: 10 weeks
serum concentration of carboxy-methyl lysine
N-telopeptide
时间窗: 10 weeks
Serum concentrations of N-telopeptide
HDL-C
时间窗: 10 weeks
Serum concentrations of High-density lipoprotein cholesterol
Systolic blood pressure
时间窗: 10 weeks
Systolic blood pressure (mmHg)
triglyceride
时间窗: 10 weeks
Serum concentrations of triglyceride
Osteoprotegerin
时间窗: 10 weeks
Serum concentrations of Osteoprotegerin
osteocalcin
时间窗: 10 weeks
Serum concentrations of osteocalcin
the Beck depression test
时间窗: 10 weeks
Score of the Beck depression test
Weight
时间窗: 10 weeks
body Weight in kilograms
The Depression Anxiety Stress Scale
时间窗: 10 weeks
Score of Depression Anxiety Stress Scale-(DASS)42
Hip circumference
时间窗: 10 weeks
Hip circumference
次要结局
- albumin(10 weeks)
- phosphorous(10 weeks)
- calcium(10 weeks)
- iPTH(10 weeks)
研究者
zahra yari
faculty
National Nutrition and Food Technology Institute