InflammationPhase 3NCT01419912
Comparison of Soy-milk and Cow Milk Consumption on Inflammatory Factors, Cardiovascular Factors ,Renal Factors, Fibrinolytic Indice and Oxidative Stress Among Type-2 Diabetic Patients With Nephropathy Stage 1 and 2
A Phase 3 study testing soy milk and cow's milk in people with Inflammation and Oxidative Stress, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on controlling complication among diabetic nephropathy patients(DN).Most studies in this regard have been examined the effect of soy consumption on cardiorenal risk factors among patients… Read more about this study
- Who is it for?
- Ages 28 to 81 years
- Conditions the study is for
- Inflammation, Oxidative Stress, Fibrinolytic Markers
- What is being tested?
- soy milk and cow's milk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteIran
- Study dates
- Start not givento not given
- Phase
- Phase 3
- 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 28 to 81 years
- All sexes
- Adult, Older adult
Who may be able to join
- adults with (>18y old) diagnosis of type 2 diabetics nephropathy (diabetics subjects that had proteinuria more than 300 mg/day and had GFR more than 90 mL/min )
Who cannot join
- exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women
- changing dosage of oral hypoglycemic agents
- insulin therapy
- lipid-lowering medications
- use of hormone replacement therapy
- alcohol and cigarette consumption;allergy or intolerance to soybeans or milk
- presence of breast malignant and avoid of advisory diet
Trial locations and contacts
1 site in 1 country.
About this study
Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on controlling complication among diabetic nephropathy patients(DN).Most studies in this regard have been examined the effect of soy consumption on cardiorenal risk factors among patients with DN and there are few data about relationship of soy milk consumption and health effect in patients with DN . Therefore, we evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation, oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients. This was a cross-over randomized clinical trial which was conducted in Isfahan among diabetic nephropathy patients. Patients were randomly assigned to consume a diet containing cow's milk or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.
- Conditions
- Inflammation, Oxidative Stress, Fibrinolytic Markers, Blood Pressure and Cardiorenal Risk Factors
- Being tested
- soy milk, cow's milk
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soy milkDietary supplement
cow's milkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| soy milk | Experimental | Not described Receives: Dietary Supplement: soy milk |
| cow's milk | Experimental | Not described Receives: Dietary Supplement: cow's milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
soy milk
Secondary outcomes (19)
HbA1c
creatinin
total cholesterol
insulin
systolic blood pressure
diastolic blood pressure
Malondialdehyde
fibrinogen
Urine creatinine
urine protein
BUN
TNF-α
IL6
FBS
TG
hs-CRP
d-dimer
HDL
LDL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InflammationStudies 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 3
- Intervention model
- Crossover
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01419912
- Sponsor's protocol ID
- soymilk and nephropathy
- Status last verified
- Jan 2011
- First submitted
- 17 Aug 2011
- Last updated
- 30 Aug 2011
- Results posted
- No
Publications
Miraghajani MS, Esmaillzadeh A, Najafabadi MM, Mirlohi M, Azadbakht L. Soy milk consumption, inflammation, coagulation, and oxidative stress among type 2 diabetic patients with nephropathy. Diabetes Care. 2012 Oct;35(10):1981-5. doi: 10.2337/dc12-0250. Epub 2012 Jul 11.
PubMed 22787172
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Soy-milk and Cow Milk Consumption on Inflammatory Factors, Cardiovascular Factors ,Renal Factors, Fibrinolytic Indice and Oxidative Stress Among Type-2 Diabetic Patients With Nephropathy Stage 1 and 2
- ClinicalTrials.gov ID
- NCT01419912
- Acronym / sponsor ID
- soymilk and nephropathy
- Conditions
- Inflammation, Oxidative Stress, Fibrinolytic Markers, Blood Pressure and Cardiorenal Risk Factors
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- First posted
- 18 Aug 2011 (estimated)
- 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.
Soymilk components such as isoflavones, essential fatty acids, phytoesterols, good fats, inositols might have beneficial effects on controlling complication among diabetic nephropathy patients(DN).Most studies in this regard have been examined the effect of soy consumption on cardiorenal risk factors among patients with DN and there are few data about relationship of soy milk consumption and health effect in patients with DN . Therefore, we evaluated the effects of soy milk compared to cow's milk on blood pressure, inflammation, oxidative stress and fibrinolytic markers and cardiorenal risk factors among these patients. This was a cross-over randomized clinical trial which was conducted in Isfahan among diabetic nephropathy patients. Patients were randomly assigned to consume a diet containing cow's milk or a diet in which only one glass of soy milk was substituted; each one for 4 weeks.
Study design
- Intervention model
- Crossover
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soy milk | Experimental | Dietary Supplement: soy milk |
| cow's milk | Experimental | Dietary Supplement: cow's milk |
Who may qualify
- Ages
- 28 to 81 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults with (>18y old) diagnosis of type 2 diabetics nephropathy (diabetics subjects that had proteinuria more than 300 mg/day and had GFR more than 90 mL/min )
Key exclusion criteria (7 listed)
- exclusion criteria included diabetic nephropathy patients that they were pregnant or lactation women
- changing dosage of oral hypoglycemic agents
- insulin therapy
- lipid-lowering medications
- use of hormone replacement therapy
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 milk | Dietary supplement | soy milk |
| cow's milk | Dietary supplement | cow's milk |
Primary outcome
soy milk
19 secondary outcomes
HbA1c
creatinin
total cholesterol
insulin
systolic blood pressure
diastolic blood pressure
Malondialdehyde
fibrinogen
Urine creatinine
urine protein
BUN
TNF-α
IL6
FBS
TG
hs-CRP
d-dimer
HDL
LDL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2011.
- Derived from this study: PubMed 22787172Miraghajani MS, Esmaillzadeh A, Najafabadi MM, Mirlohi M, Azadbakht L. Soy milk consumption, inflammation, coagulation, and oxidative stress among type 2 diabetic patients with nephropathy. Diabetes Care. 2012 Oct;35(10):1981-5. doi: 10.2337/dc12-0250. Epub 2012 Jul 11.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing soy milk and cow's milk in people with Inflammation and Oxidative Stress, run by Isfahan University of Medical Sciences 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 7 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: finished, as of the sponsor's last update on 30 Aug 2011. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
soy milk. 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 NCT01419912, which also lists 1 linked publication.
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 30 Aug 2011.