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Long-Term Effect of Soy Consumption on Cardio-Renal Indices and CRP in Type 2diabetes With Nephropathy

NCT ID: NCT00555490

Last Updated: 2007-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2005-09-30

Brief Summary

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we conducted a longitudinal 4-year clinical trial to determine the long-term effects of soy consumption on lipid profiles, renal-function indices and CRP level among type 2 diabetic patients with nephropathy.

Detailed Description

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Background: Several short-term trials on the effect of soy consumption on cardiovascular risks are available, but little evidence exists regarding the impact of long-term soy protein consumption among type 2 diabetic patients with nephropathy.

Objectives: To determine the effects of long-term soy consumption on cardiovascular risks, C-reactive protein and kidney-function indices among type 2 diabetic patients with nephropathy.

Design: This longitudinal randomized clinical trial was conducted among 41 type 2 diabetic patients with nephropathy (18 men and 23 women). Twenty patients in soy protein group consumed a diet containing 0.8 g protein/kg body weight (35% animal proteins, 35% textured soy protein, and 30% vegetable proteins) and 21 patients in control group consumed a similar diet containing 70% animal proteins and 30% vegetable proteins for 4-years.

Conditions

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Kidney Transplantation

Keywords

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Soy Diabetes Nephropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

Soy protein

Intervention Type DIETARY_SUPPLEMENT

35 % of protein from soy protein for 4-years

Interventions

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Soy protein

35 % of protein from soy protein for 4-years

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Type 2 Diabetes with Nephrophaty

Exclusion Criteria

* Dialysis
* Transplantation
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Isfahan University of Medical Sciences

OTHER

Sponsor Role lead

Principal Investigators

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Leila Azadbakht, PhD

Role: PRINCIPAL_INVESTIGATOR

Isfahan University of Medical Sciences, School of Health

Other Identifiers

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IsfahanUMS

Identifier Type: -

Identifier Source: org_study_id