NCT00555490

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2001

Longer than P75 for phase_1

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2001

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
Last Updated

November 8, 2007

Status Verified

November 1, 2007

First QC Date

November 7, 2007

Last Update Submit

November 7, 2007

Conditions

Kidney Transplantation

Keywords

SoyDiabetesNephropathy

Outcome Measures

Primary Outcomes (1)

  • mortality or using dialysis

    4-years

Study Arms (1)

1

EXPERIMENTAL
Dietary Supplement: Soy protein

Interventions

Soy proteinDIETARY_SUPPLEMENT

35 % of protein from soy protein for 4-years

1

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 Diabetes with Nephrophaty

You may not qualify if:

  • Dialysis
  • Transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes MellitusKidney Diseases

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Plant ProteinsProteinsAmino Acids, Peptides, and ProteinsPlant Proteins, DietaryDietary ProteinsFoodDiet, Food, and NutritionPhysiological PhenomenaSoy FoodsVegetable ProductsVegetablesFood and Beverages

Study Officials

  • Leila Azadbakht, PhD

    Isfahan University of Medical Sciences, School of Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 8, 2007

Study Start

April 1, 2001

Study Completion

September 1, 2005

Last Updated

November 8, 2007

Record last verified: 2007-11