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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00555490
Other study ID # IsfahanUMS
Secondary ID
Status Completed
Phase Phase 1
First received November 7, 2007
Last updated November 7, 2007
Start date April 2001
Est. completion date September 2005

Study information

Verified date November 2007
Source Isfahan University of Medical Sciences
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 41
Est. completion date September 2005
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Type 2 Diabetes with Nephrophaty

Exclusion Criteria:

- Dialysis

- Transplantation

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Soy protein
35 % of protein from soy protein for 4-years

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Isfahan University of Medical Sciences hahid Beheshti University of Medical Sciences

Outcome

Type Measure Description Time frame Safety issue
Primary mortality or using dialysis 4-years
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