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CompletedNCT02704884Updated Aug 15, 2016

Microbial Soy Milk Consumption, Inflammation and Renal Function Among Type 2 Diabetic Patients With Nephropathy

An interventional study of probiotic soy milk in Type II Diabetic Patients With Nephropathy, sponsored by Isfahan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 32 Years to 68 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-08-15.

Sponsored by Isfahan University of Medical Sciences · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
32 Years to 68 Years
Sex
All
01

Study summary

The aim of the present study was to determine the effects of fortified soy milk with L. planetarium A7 on a cytokine receptor, an adipokine and renal function biomarkers in type II diabetic patients with nephropathy.

02

Conditions studied

  • Type II Diabetic Patients With Nephropathy

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03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 48 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

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Lead sponsor

Isfahan University of Medical Sciences is the lead sponsor of 145 studies on the registry; 8 are open to participants now.

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

04

Who can participate

Ages eligible
32 Years to 68 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults
  • Type 2 diabetic patients with stages 1 and 2 of nephropathy (defined as meeting criteria including fasting blood glucose >126 mg/dL, hypoglycemic agents, or insulin intake, proteinuria >300 mg/day, and glomerular filtration rate >90 mL/min)

Exclusion criteria

Exclusion Criteria:

  • pregnancy or lactating in women
  • allergy or intolerance to soy milk or avoidance of soy milk consumption
  • smoking, alcoholism
  • recent antibiotic therapy and using of supplements containing vitamins and minerals
  • any medical condition such as inflammatory bowel disease, infection, liver disease and rheumatoid arthritis.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    probiotic soy milk

    consume a diet containing 200 ml/day probiotic soy milk in intervention group

    Dietary Supplement: probiotic soy milk

  • Active comparator
    soy milk

    200 ml/day soy milk in the control condition

    Dietary Supplement: probiotic soy milk

Interventions

  • Dietary supplementprobiotic soy milk
06

What researchers measure

Primary outcomes

  1. inflammatory adipokine- Progranulin (PGRN)

    PGRN will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China).

    Time frame: 8 week

  2. cytokine receptor -soluble tumor necrosis factor receptor 1 (sTNFR1),

    sTNFR1 will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China).

    Time frame: 8 week

  3. serum levels of Neutrophil gelatinase-associated lipocalin (NGAL)

    NGAL will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China).

    Time frame: 8 week

  4. cystatin C (Cys- C)

    Cys- C will determine by commercial sandwich enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's protocols. (Human ELISA kits, Shanghai Crystal Day Biotech Company, China).

    Time frame: 8 week

07

Study locations

1 site
  • Makan Pourmasoumi
    Tehran, 1353, Iran, Islamic Republic of
08

References and documents

Publications

  • Miraghajani M, Zaghian N, Mirlohi M, Feizi A, Ghiasvand R. The Impact of Probiotic Soy Milk Consumption on Oxidative Stress Among Type 2 Diabetic Kidney Disease Patients: A Randomized Controlled Clinical Trial. J Ren Nutr. 2017 Sep;27(5):317-324. doi: 10.1053/j.jrn.2017.04.004. Epub 2017 May 31. PubMed 28579313 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02704884
Lead sponsor
Isfahan University of Medical Sciences
Responsible party
Makan Pourmasoumi (MSc student, Principal Investigator, Department of Community Nutrition, School of Nutrition and Food Science, Isfahan University of Medical Sciences, Isfahan, Iran, Isfahan University of Medical Sciences) — Principal investigator
First posted
Mar 10, 2016
Start date
Mar 2016
Primary completion
Jun 2016
Last update
Aug 15, 2016
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.

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