ClinicalTrials.gg
Sign In
Not yet recruitingNCT06160830Updated Dec 7, 2023

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

An interventional study of synbiotic and placebo in Transplanted Kidney, sponsored by National Nutrition and Food Technology Institute. Not yet recruiting. Open to participants aged 16 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by National Nutrition and Food Technology Institute · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Apr 2024, 2 years 7 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
44
Allocation
Randomized
Ages
16 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Transplanted Kidney
03

In context

Lead sponsor

National Nutrition and Food Technology Institute is the lead sponsor of 63 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • \<35 kg/m2

Exclusion criteria

Exclusion Criteria:

  • Receiving synbiotic supplement
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
44 participants (estimated)

Study arms

  • Active comparator
    synbiotic

    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 comparator
    placebo

    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

  • Dietary supplementsynbiotic

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

  • Otherplacebo

    Two capsules of placebo containing maltodextrin per day

06

What researchers measure

Primary outcomes

  1. Lp (a)

    Serum concentrations of lipoprotein-a

    Time frame: 10 weeks

  2. MDA

    Serum concentrations of malondialdehyde

    Time frame: 10 weeks

  3. hs-CRP

    Serum concentrations of high sensitivity c-reactive protein

    Time frame: 10 weeks

  4. sICAM-1

    Serum concentrations of Soluble intercellular adhesion molecule-1

    Time frame: 10 weeks

  5. glucose

    serum concentration of fasting glucose

    Time frame: 10 weeks

  6. pentosidine

    serum concentration of pentosidine

    Time frame: 10 weeks

  7. carboxy-methyl lysine

    serum concentration of carboxy-methyl lysine

    Time frame: 10 weeks

  8. Osteoprotegerin

    Serum concentrations of Osteoprotegerin

    Time frame: 10 weeks

  9. osteocalcin

    Serum concentrations of osteocalcin

    Time frame: 10 weeks

  10. RANKL

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

    Time frame: 10 weeks

  11. Systolic blood pressure

    Systolic blood pressure (mmHg)

    Time frame: 10 weeks

  12. Diastolic blood pressure

    Diastolic blood pressure (mmHg)

    Time frame: 10 weeks

  13. N-telopeptide

    Serum concentrations of N-telopeptide

    Time frame: 10 weeks

  14. triglyceride

    Serum concentrations of triglyceride

    Time frame: 10 weeks

  15. Total cholesterol

    Serum concentrations of total cholesterol

    Time frame: 10 weeks

  16. HDL-C

    Serum concentrations of High-density lipoprotein cholesterol

    Time frame: 10 weeks

  17. LDL-C

    Serum concentrations of low-density lipoprotein cholesterol

    Time frame: 10 weeks

  18. the Beck depression test

    Score of the Beck depression test

    Time frame: 10 weeks

  19. The Depression Anxiety Stress Scale

    Score of Depression Anxiety Stress Scale-(DASS)42

    Time frame: 10 weeks

  20. Weight

    body Weight in kilograms

    Time frame: 10 weeks

  21. Waist circumference

    Waist circumference

    Time frame: 10 weeks

  22. Hip circumference

    Hip circumference

    Time frame: 10 weeks

Secondary outcomes

  1. albumin

    Serum concentrations of albumin

    Time frame: 10 weeks

  2. calcium

    Serum concentrations of calcium

    Time frame: 10 weeks

  3. phosphorous

    Serum concentrations of phosphorous

    Time frame: 10 weeks

  4. iPTH

    Serum concentrations of Intact parathyroid hormone

    Time frame: 10 weeks

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2023; primary completion for Apr 2024, 4 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 29, 2023
First posted
Dec 7, 2023
StartEst.
Dec 1, 2023
Primary completionEst.
Apr 1, 2024
CompletionEst.
May 1, 2024
Last update
Dec 7, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06160830
Lead sponsor
National Nutrition and Food Technology Institute
Responsible party
zahra yari (faculty, National Nutrition and Food Technology Institute) — Principal investigator
First posted
Dec 7, 2023
Start date
Dec 1, 2023 (estimated)
Primary completion
Apr 1, 2024 (estimated)
Completion
May 1, 2024 (estimated)
Last update
Dec 7, 2023

Study contacts

zahra yari, PhD
Contact
zahrayari_nut@yahoo.com
+982122357484

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

National Nutrition and Food Technology Institute

Start the discussion