Transplanted KidneyNCT06160830
The Effects of Synbiotic on Cardiovascular and Bone Metabolism Markers in Transplanted Kidney Patients
A study testing synbiotic in people with Transplanted Kidney, run by National Nutrition and Food Technology Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Transplanted Kidney
- What is being tested?
- synbiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- : 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
Who cannot join
- Receiving synbiotic supplement
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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
- Being tested
- synbiotic, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
synbioticDietary supplement
Two capsules of synbiotic per day, each containing 500 mg of synbiotic
placeboOther
Two capsules of placebo containing maltodextrin per day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lp (a)
Serum concentrations of lipoprotein-a
Measured: 10 weeks
MDA
Serum concentrations of malondialdehyde
Measured: 10 weeks
hs-CRP
Serum concentrations of high sensitivity c-reactive protein
Measured: 10 weeks
sICAM-1
Serum concentrations of Soluble intercellular adhesion molecule-1
Measured: 10 weeks
glucose
serum concentration of fasting glucose
Measured: 10 weeks
pentosidine
serum concentration of pentosidine
Measured: 10 weeks
carboxy-methyl lysine
serum concentration of carboxy-methyl lysine
Measured: 10 weeks
Osteoprotegerin
Serum concentrations of Osteoprotegerin
Measured: 10 weeks
osteocalcin
Serum concentrations of osteocalcin
Measured: 10 weeks
RANKL
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Measured: 10 weeks
Systolic blood pressure
Systolic blood pressure (mmHg)
Measured: 10 weeks
Diastolic blood pressure
Diastolic blood pressure (mmHg)
Measured: 10 weeks
N-telopeptide
Serum concentrations of N-telopeptide
Measured: 10 weeks
triglyceride
Serum concentrations of triglyceride
Measured: 10 weeks
Total cholesterol
Serum concentrations of total cholesterol
Measured: 10 weeks
HDL-C
Serum concentrations of High-density lipoprotein cholesterol
Measured: 10 weeks
LDL-C
Serum concentrations of low-density lipoprotein cholesterol
Measured: 10 weeks
the Beck depression test
Score of the Beck depression test
Measured: 10 weeks
The Depression Anxiety Stress Scale
Score of Depression Anxiety Stress Scale-(DASS)42
Measured: 10 weeks
Weight
body Weight in kilograms
Measured: 10 weeks
Waist circumference
Waist circumference
Measured: 10 weeks
Hip circumference
Hip circumference
Measured: 10 weeks
Secondary outcomes (4)
albumin
Serum concentrations of albumin
Measured: 10 weeks
calcium
Serum concentrations of calcium
Measured: 10 weeks
phosphorous
Serum concentrations of phosphorous
Measured: 10 weeks
iPTH
Serum concentrations of Intact parathyroid hormone
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 Dec 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplanted KidneyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Nutrition and Food Technology Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, zahra yari, National Nutrition and Food Technology Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06160830
- Sponsor's protocol ID
- 051
- Status last verified
- Nov 2023
- First submitted
- 29 Nov 2023
- Last updated
- 7 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06160830
- Acronym / sponsor ID
- 051
- Conditions
- Transplanted Kidney
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| synbiotic | Active comparator | Dietary Supplement: synbioticPatients 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. |
| placebo | Placebo comparator | Other: placeboPatients 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. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- : 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
Key exclusion criteria (1 listed)
- Receiving synbiotic supplement
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| synbioticTwo capsules of synbiotic per day, each containing 500 mg of synbiotic | Dietary supplement | synbiotic |
| placeboTwo capsules of placebo containing maltodextrin per day | Other | placebo |
Primary outcome
Lp (a)
Time frame: 10 weeks
Serum concentrations of lipoprotein-a
MDA
Time frame: 10 weeks
Serum concentrations of malondialdehyde
hs-CRP
Time frame: 10 weeks
Serum concentrations of high sensitivity c-reactive protein
sICAM-1
Time frame: 10 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
glucose
Time frame: 10 weeks
serum concentration of fasting glucose
pentosidine
Time frame: 10 weeks
serum concentration of pentosidine
carboxy-methyl lysine
Time frame: 10 weeks
serum concentration of carboxy-methyl lysine
Osteoprotegerin
Time frame: 10 weeks
Serum concentrations of Osteoprotegerin
osteocalcin
Time frame: 10 weeks
Serum concentrations of osteocalcin
RANKL
Time frame: 10 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Systolic blood pressure
Time frame: 10 weeks
Systolic blood pressure (mmHg)
Diastolic blood pressure
Time frame: 10 weeks
Diastolic blood pressure (mmHg)
N-telopeptide
Time frame: 10 weeks
Serum concentrations of N-telopeptide
triglyceride
Time frame: 10 weeks
Serum concentrations of triglyceride
Total cholesterol
Time frame: 10 weeks
Serum concentrations of total cholesterol
HDL-C
Time frame: 10 weeks
Serum concentrations of High-density lipoprotein cholesterol
LDL-C
Time frame: 10 weeks
Serum concentrations of low-density lipoprotein cholesterol
the Beck depression test
Time frame: 10 weeks
Score of the Beck depression test
The Depression Anxiety Stress Scale
Time frame: 10 weeks
Score of Depression Anxiety Stress Scale-(DASS)42
Weight
Time frame: 10 weeks
body Weight in kilograms
Waist circumference
Time frame: 10 weeks
Waist circumference
Hip circumference
Time frame: 10 weeks
Hip circumference
4 secondary outcomes
albumin
Time frame: 10 weeks
calcium
Time frame: 10 weeks
phosphorous
Time frame: 10 weeks
iPTH
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2023.
Related trials for Transplanted Kidney
Enrolling by invitation
Online Exercise Program for Transplant Patients: A Pilot Study
Kidney Transplantation, Physical Function
RecruitingPhase 2
A Study of Mezagitamab in Adults With Late Antibody-Mediated Rejection (AMR) After a Kidney Transplant
Antibody-Mediated Rejection (AMR)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruitingEarly Phase 1
Biomarker-Guided Mycophenolate Mofetil Elimination in Low-Risk Older Adult Kidney Transplant Recipients
Kidney Transplant Recipient
Recruiting
Non-Invasive Monitoring of Pediatric Kidney Transplant Recipients and Immunosuppression Personalization: an Open-labeled Multicenter Randomized Controlled Study
Pediatric Kidney Disease, Transplant;Failure,Kidney
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing synbiotic in people with Transplanted Kidney, run by National Nutrition and Food Technology Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact zahra yari, PhD (+982122357484, zahrayari_nut@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lp (a) (time frame: 10 weeks). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2023.