NCT01906086

Brief Summary

The aim of this randomized cross-over study was to determine the effects of legume consumption on adiponectin and inflammatory 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

June 25, 2013

Completed
28 days until next milestone

First Posted

Study publicly available on registry

July 23, 2013

Completed
Last Updated

May 20, 2014

Status Verified

May 1, 2014

Enrollment Period

4 months

First QC Date

June 25, 2013

Last Update Submit

May 16, 2014

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • high sensitive C reactive protein (mg/l)

    amounts of hs-CRP

    14 weeks

Secondary Outcomes (3)

  • Interleukin-6 (pg/ml)

    14 weeks

  • Tumor necrosis factor-α (pg/ml)

    14 weeks

  • Adiponectin (ng/ml)

    14 weeks

Study Arms (2)

legume consumption

EXPERIMENTAL

legume consumption, 4 servings per week, for 6 weeks

Other: nutritional intervention

healthy dietary recommendations

ACTIVE COMPARATOR

no nutritional intervention

Other: life style intervention

Interventions

nutritional interventionOTHER
legume consumption
life style interventionOTHER
healthy dietary recommendations

Eligibility Criteria

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

You may qualify if:

  • age more than 30 years
  • no history of chronic diseases
  • no use of blood glucose lowering drugs

You may not qualify if:

  • do not use recommended amounts of legumes
  • incidence of chronic diseases during the study
  • to start use of blood glucose lowering drugs

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

June 25, 2013

First Posted

July 23, 2013

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

May 20, 2014

Record last verified: 2014-05

Locations

IR(1)