Peritoneal Dialysis PatientsNCT03773029
The Effects of Isoflavones on Cardiovascular and Bone Metabolism Markers in Peritoneal Dialysis Patients
A study testing soy isoflavone in people with Peritoneal Dialysis Patients, run by National Nutrition and Food Technology Institute at 1 site in Iran.
Trial summary
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Dialysis Patients
- What is being tested?
- soy isoflavone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteIran
- Study dates
- 1 Jan 2019to Nov 2019
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35
Who cannot join
- infections inflammatory diseases; liver diseases; past medical history of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
National Nutrition and Food Technology Research Institute
Tehran, Iran (the Islamic Republic Of), 1981619573
Zahra Yari, +982122357484, zahrayari_nut@yahoo.com
About this study
Official title: Effects of Isoflavones on Cardiovascular Disease Risk Factors, Bone Metabolism Markers, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients
The aim of this double-blind randomized clinical trial is to determine the effects of isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic and Dr.najafi's clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of Lp (a), MDA, hs-CRP, sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH, triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine, pentosidine, glucose, albumin, calcium and phosphorous will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing
- Conditions
- Peritoneal Dialysis Patients
- Being tested
- soy isoflavone, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy isoflavoneDietary supplement
100 mg soy isoflavone (as 2 capsules)
placeboOther
2 capsules of placebo
| Study group | Role | What they receive |
|---|---|---|
| isoflavone | Active comparator | 100 mg soy isoflavone (as 2 capsules) Receives: Dietary Supplement: soy isoflavone |
| control | Placebo comparator | 2 capsules of placebo 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: 8 weeks
MDA
Serum concentrations of malondialdehyde
Measured: 8 weeks
hs-CRP
Serum concentrations of high sensitivity c-reactive protein
Measured: 8 weeks
sICAM-1
Serum concentrations of Soluble intercellular adhesion molecule-1
Measured: 8 weeks
bone alkaline phosphatase
Serum concentrations of bone alkaline phosphatase
Measured: 8 weeks
osteocalcin
Serum concentrations of osteocalcin
Measured: 8 weeks
N-telopeptide
Serum concentrations of N-telopeptide
Measured: 8 weeks
Osteoprotegerin
Serum concentrations of Osteoprotegerin
Measured: 8 weeks
RANKL
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
Measured: 8 weeks
triglyceride
Serum concentrations of triglyceride
Measured: 8 weeks
total cholesterol
Serum concentrations of total cholesterol
Measured: 8 weeks
HDL-C
Serum concentrations of High-density lipoprotein cholesterol
Measured: 8 weeks
LDL-C
Serum concentrations of low-density lipoprotein cholesterol
Measured: 8 weeks
sVCAM-1
Serum concentrations of Soluble vascular adhesion molecule-1
Measured: 8 weeks
E-selectin
Serum concentrations of E-selectin
Measured: 8 weeks
Secondary outcomes (4)
albumin
Serum concentrations of albumin
Measured: 8 weeks
calcium
Serum concentrations of calcium
Measured: 8 weeks
phosphorous
Serum concentrations of phosphorous
Measured: 8 weeks
iPTH
Serum concentrations of Intact parathyroid hormone
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start1 Jan 2019
- Primary completion1 Apr 2019
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Dialysis PatientsStudies 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
- 47 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
- NCT03773029
- Sponsor's protocol ID
- 1397.247
- Status last verified
- Dec 2018
- First submitted
- 10 Dec 2018
- Last updated
- 19 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yari Z, Tabibi H, Najafi I, Hedayati M, Movahedian M. Effects of soy isoflavones on serum lipids and lipoprotein (a) in peritoneal dialysis patients. Nutr Metab Cardiovasc Dis. 2020 Jul 24;30(8):1382-1388. doi: 10.1016/j.numecd.2020.04.023. Epub 2020 May 5.
PubMed 32513581Yari Z, Tabibi H, Najafi I, Hedayati M, Movahedian M. Effects of isoflavones on bone turnover markers in peritoneal dialysis patients: a randomized controlled trial. Int Urol Nephrol. 2020 Jul;52(7):1367-1376. doi: 10.1007/s11255-020-02523-w. Epub 2020 Jun 1.
PubMed 32488754
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Isoflavones on Cardiovascular Disease Risk Factors, Bone Metabolism Markers, Serum Concentrations of Fructoseamine and Advanced Glycated End Products in Peritoneal Dialysis Patients
- ClinicalTrials.gov ID
- NCT03773029
- Acronym / sponsor ID
- 1397.247
- Conditions
- Peritoneal Dialysis Patients
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- National Nutrition and Food Technology InstituteUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Apr 2019 (actual)
- Study completion
- Nov 2019 (estimated)
- First posted
- 12 Dec 2018 (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 isoflavones on cardiovascular disease risk factors, bone metabolism markers, serum concentrations of fructoseamine and advanced glycated end products in peritoneal dialysis patients. Forty-four patients from shafa clinic and Dr.najafi's clinic will randomly assign to either isoflavone or placebo group. The patients in isoflavone group will receive 100 mg soy isoflavone (as 2 capsules) daily for 8 weeks, while the placebo group will receive identical placebo. At the baseline and the end of the study,7 ml blood will be collected from each patient after a 12-14-hours fasting and serum concentrations of Lp (a), MDA, hs-CRP, sICAM-1, bone alkaline phosphatase, osteocalcin, N-telopeptide, osteoprotegerin, RANKL, iPTH, triglyceride, total cholesterol, HDL-C, LDL-C, fructoseamine, carboxymethyl lysine, pentosidine, glucose, albumin, calcium and phosphorous will be measured. Furthermore, blood pressure measurements will be performed twice with a ten-minute interval between testing
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 |
|---|---|---|
| isoflavone | Active comparator | Dietary Supplement: soy isoflavone100 mg soy isoflavone (as 2 capsules) |
| control | Placebo comparator | Other: placebo2 capsules of placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Continuous Ambulatory Peritoneal Dialysis for 6 months or more Body mass index below 35
Key exclusion criteria (1 listed)
- infections inflammatory diseases; liver diseases; past medical history of cancer receiving glucocorticoid and anti-inflammatory drugs receiving isoflavone supplements Constant consumption of soy or foods containing soy in the diet
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 |
|---|---|---|
| soy isoflavone100 mg soy isoflavone (as 2 capsules) | Dietary supplement | isoflavone |
| placebo2 capsules of placebo | Other | control |
Primary outcome
Lp (a)
Time frame: 8 weeks
Serum concentrations of lipoprotein-a
MDA
Time frame: 8 weeks
Serum concentrations of malondialdehyde
hs-CRP
Time frame: 8 weeks
Serum concentrations of high sensitivity c-reactive protein
sICAM-1
Time frame: 8 weeks
Serum concentrations of Soluble intercellular adhesion molecule-1
bone alkaline phosphatase
Time frame: 8 weeks
Serum concentrations of bone alkaline phosphatase
osteocalcin
Time frame: 8 weeks
Serum concentrations of osteocalcin
N-telopeptide
Time frame: 8 weeks
Serum concentrations of N-telopeptide
Osteoprotegerin
Time frame: 8 weeks
Serum concentrations of Osteoprotegerin
RANKL
Time frame: 8 weeks
Serum concentrations of Receptor activator of nuclear factor kappa-Β ligand
triglyceride
Time frame: 8 weeks
Serum concentrations of triglyceride
total cholesterol
Time frame: 8 weeks
Serum concentrations of total cholesterol
HDL-C
Time frame: 8 weeks
Serum concentrations of High-density lipoprotein cholesterol
LDL-C
Time frame: 8 weeks
Serum concentrations of low-density lipoprotein cholesterol
sVCAM-1
Time frame: 8 weeks
Serum concentrations of Soluble vascular adhesion molecule-1
E-selectin
Time frame: 8 weeks
Serum concentrations of E-selectin
4 secondary outcomes
albumin
Time frame: 8 weeks
calcium
Time frame: 8 weeks
phosphorous
Time frame: 8 weeks
iPTH
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2019.
- Derived from this study: PubMed 32513581Yari Z, Tabibi H, Najafi I, Hedayati M, Movahedian M. Effects of soy isoflavones on serum lipids and lipoprotein (a) in peritoneal dialysis patients. Nutr Metab Cardiovasc Dis. 2020 Jul 24;30(8):1382-1388. doi: 10.1016/j.numecd.2020.04.023. Epub 2020 May 5.
- Derived from this study: PubMed 32488754Yari Z, Tabibi H, Najafi I, Hedayati M, Movahedian M. Effects of isoflavones on bone turnover markers in peritoneal dialysis patients: a randomized controlled trial. Int Urol Nephrol. 2020 Jul;52(7):1367-1376. doi: 10.1007/s11255-020-02523-w. Epub 2020 Jun 1.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing soy isoflavone in people with Peritoneal Dialysis Patients, run by National Nutrition and Food Technology Institute at 1 site in Iran.
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 1 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 19 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
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 (+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: 8 weeks). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03773029, which also lists 2 linked publications.
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 19 Nov 2019.