Trials / Unknown
UnknownNCT06160830
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
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 44 (estimated)
- Sponsor
- National Nutrition and Food Technology Institute · Academic / Other
- Sex
- All
- Age
- 16 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2024-04-01
- Completion
- 2024-05-01
- First posted
- 2023-12-07
- Last updated
- 2023-12-07
Source: ClinicalTrials.gov record NCT06160830. Inclusion in this directory is not an endorsement.