NCT01906099

Brief Summary

This randomized cross-over study was designed to investigate the effects of legume enriched diet consumption on cardiovascular risk factors among first degree relatives of diabetic patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2012

Shorter than P25 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

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

September 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 9, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
Last Updated

July 23, 2013

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

July 9, 2013

Last Update Submit

July 18, 2013

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • Fasting blood glucose (mg/dl)

    amounts of FBG

    14 weeks

Secondary Outcomes (5)

  • Hemoglobin A1C (%)

    14 weeks

  • Total cholesterol (mg/dl)

    14 weeks

  • Low Density Lipoprotein (mg/dl)

    14 weeks

  • High Density Lipoprotein (mg/dl)

    14 weeks

  • Triglyceride (mg/dl)

    14 weeks

Study Arms (2)

legume enriched diet

EXPERIMENTAL

legume consumption, 4 servings per week, for 6 weeks

Other: nutritional intervention

healthy dietary recommendations

ACTIVE COMPARATOR

no nutritional intervention

Other: life style modification

Interventions

nutritional interventionOTHER
legume enriched diet
life style modificationOTHER
healthy dietary recommendations

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • subjects aged more than 30 years
  • no history of chronic diseases
  • no use of blood glucose lowering drugs be wiling to participate to study

You may not qualify if:

  • do not follow study protocol
  • incidence of chronic diseases during the study
  • to start use of blood glucose lowering drugs or to change dose and type of current medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isfahan University of Medical Sciences

Isfahan, Iran

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Isfahan University of Medical Sciences

Study Record Dates

First Submitted

July 9, 2013

First Posted

July 23, 2013

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

July 23, 2013

Record last verified: 2013-07

Locations

IR(1)