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

NCT06160830 | Unknown

• 1 other identifier: 051
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Transplanted Kidney

Outcome Measures

Primary Outcomes (22)

• Lp (a)

  Serum concentrations of lipoprotein-a

  10 weeks

• MDA

  Serum concentrations of malondialdehyde

  10 weeks

• hs-CRP

  Serum concentrations of high sensitivity c-reactive protein

  10 weeks

• sICAM-1

  Serum concentrations of Soluble intercellular adhesion molecule-1

  10 weeks

• glucose

  serum concentration of fasting glucose

  10 weeks

• pentosidine

  serum concentration of pentosidine

  10 weeks

• carboxy-methyl lysine

  serum concentration of carboxy-methyl lysine

  10 weeks

• Osteoprotegerin

  Serum concentrations of Osteoprotegerin

  10 weeks

• osteocalcin

  Serum concentrations of osteocalcin

  10 weeks

• RANKL

  Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand

  10 weeks

• Systolic blood pressure

  Systolic blood pressure (mmHg)

  10 weeks

• Diastolic blood pressure

  Diastolic blood pressure (mmHg)

  10 weeks

• N-telopeptide

  Serum concentrations of N-telopeptide

  10 weeks

• triglyceride

  Serum concentrations of triglyceride

  10 weeks

• Total cholesterol

  Serum concentrations of total cholesterol

  10 weeks

• HDL-C

  Serum concentrations of High-density lipoprotein cholesterol

  10 weeks

• LDL-C

  Serum concentrations of low-density lipoprotein cholesterol

  10 weeks

• the Beck depression test

  Score of the Beck depression test

  10 weeks

• The Depression Anxiety Stress Scale

  Score of Depression Anxiety Stress Scale-(DASS)42

  10 weeks

• Weight

  body Weight in kilograms

  10 weeks

• Waist circumference

  Waist circumference

  10 weeks

• Hip circumference

  Hip circumference

  10 weeks

Secondary Outcomes (4)

• albumin

  10 weeks

• calcium

  10 weeks

• phosphorous

  10 weeks

• iPTH

  10 weeks

Study Arms (2)

synbiotic

ACTIVE COMPARATOR

Patients in the synbiotic group will receive, for 10-12 weeks, Two capsules of synbiotic (Zist Takhmir Company) per day, each containing 500 mg of synbiotic. Patients in this group received a multispecies probiotic product (109 CFU/capsule) and fructo oligosaccharid as prebiotics.

Dietary Supplement: synbiotic

placebo

PLACEBO COMPARATOR

Patients in the placebo group will receive Two capsules of placebo containing maltodextrin per day. The placebo powder will comparable in color, texture, and taste to the synbiotics. Supplement packaging will be done by Zist Takhmir Company.

Other: placebo

Interventions

synbiotic DIETARY_SUPPLEMENT

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

synbiotic

placebo OTHER

Two capsules of placebo containing maltodextrin per day

placebo

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• : 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

You may not qualify if:

• Receiving synbiotic supplement

Sponsors & Collaborators

• National Nutrition and Food Technology Institute: lead

MeSH Terms

Interventions

Synbiotics

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Central Study Contacts

zahra yari, PhD

CONTACT

+982122357484; zahrayari_nut@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: faculty

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: December 7, 2023
• Study Start: December 1, 2023
• Primary Completion: April 1, 2024
• Study Completion: May 1, 2024
• Last Updated: December 7, 2023

Record last verified: 2023-11