NCT01397942

Brief Summary

To investigate if a high dietary intake of bitter and strong tasting vegetables have positive health effects (insulin sensitivity, glucose tolerance, central obesity, fasting and postprandial lipid profile, blood pressure, vitamin D status and inflammatory markers, biomarkers of oxidative stress) on subjects with T2D. Also to look at a high dietary intake of mild and sweet modern vegetables or a normal western diet.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
92

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable type-2-diabetes

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

May 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 20, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

3.6 years

First QC Date

July 18, 2011

Last Update Submit

March 10, 2015

Conditions

Type 2 Diabetes

Keywords

Diet interventionType 2 diabetesVegetablesPhytochemicals

Outcome Measures

Primary Outcomes (1)

  • Insulin sensitivity

    Measured as the AUC from an Oral Glucose Tolerance Test

    2 years

Secondary Outcomes (1)

  • Urine and blood samples

    2 years

Study Arms (3)

Diet intervention - Ancient vegatables

EXPERIMENTAL

A healthy Nordic diet with high content of bitter strong tasting vegetables and cabbages.

Other: Diet intervention

Control Nordic diet

NO INTERVENTION

A diet habitually consumed in the Nordic countries

Diet intervention - Modern Vegetables

EXPERIMENTAL

A healthy Nordic diet with high content of sweet and mild tasting vegetables and cabbages.

Other: Diet intervention

Interventions

Diet interventionOTHER

The participants in the two experimental arms will each have to consume 500 g of vegetables and cabbages daily.

Also known as: Vegetables, Ancient, Cabbages, Type 2 diabetes
Diet intervention - Ancient vegatablesDiet intervention - Modern Vegetables

Eligibility Criteria

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

You may qualify if:

  • Type 2 diabetes in diet treatment or on oral anti-diabetic drug or the metabolic syndrome.

You may not qualify if:

  • Other severe diseases or in treatment with insulin, GLP-1 analogs, glitazones.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vendsyssel, Center for Clinical Research

Hjørring, North Denmark, 9800, Denmark

Location

Related Links

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Vegetables

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Per B Jeppesen, Prof. PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate prof., PhD

Study Record Dates

First Submitted

July 18, 2011

First Posted

July 20, 2011

Study Start

May 1, 2011

Primary Completion

December 1, 2014

Study Completion

January 1, 2015

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

DK(1)