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OpenTrials
Completed

NCT Number: NCT02704884

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

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.

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Key information

Conditions

Type II Diabetic Patients With Nephropathy

Age range

32 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Makan Pourmasoumi

Tehran, 1353, Iran

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

probiotic soy milk

Dietary Supplement

Primary outcomes

  1. inflammatory adipokine- Progranulin (PGRN)

    Time frame: 8 week

    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).

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

    Time frame: 8 week

    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).

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

    Time frame: 8 week

    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).

  4. cystatin C (Cys- C)

    Time frame: 8 week

    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).

Sponsors and collaborators

Lead sponsor

Isfahan University of Medical Sciences

Other

Registry information

Important dates

Study start
2016
Primary completion
2016
First posted
Mar 10, 2016
Registry last updated
Aug 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.