Two Pieces of Fruit to Type 2 Diabetics?

March 20, 2013 updated by: Allan Stubbe Christensen, Hospitalsenheden Vest

It has been questioned whether patients with type 2 diabetes who are advised to restrict their fruit consumption to two or less pieces of fruits daily have better outcomes (HbA1c, body weight, fruit intake and serum lipids) after three months compared to patients with type 2 diabetes who are advised to eat at least two pieces of fruits.

To the investigators' knowledge, no randomized controlled trial has evaluated this.

The investigators therefore perform a randomized controlled trial including 76 patients with type 2 diabetes to investigate this.

The investigators' hypothesis is that:

Type 2 diabetics who are advised to restrict their fruit consumption have the same Hba1c three months after an initially dietary treatment as type 2 diabetics who are advised not to restrict their fruit consumption.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Holstebro, Denmark, 7500
        • Department of nutrition, Regional Hospital West Jutland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients refered from a general practitioner

Exclusion Criteria:

  • no Hba1c when refered
  • Hba1c lower than 5% or higher than 12%
  • patients that require a translator
  • patients with severe cardiovascular, renal or endocrine disease
  • psychiatric patients
  • pregnant patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Fruit restricted
Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.
Behavioral: dietary treatment
A standard dietary treatment except that they are advised to restrict their fruit intake.
Behavioral: dietary treatment
A standard dietary treatment.
ACTIVE_COMPARATOR: Fruit ad libitum
Type 2 diabetics are advised to eat at least two pieces of fruits daily
Behavioral: dietary treatment
A standard dietary treatment except that they are advised to restrict their fruit intake.
Behavioral: dietary treatment
A standard dietary treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Hba1c
Time Frame: three months
three months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in bodyweight
Time Frame: three months
three months
change in serum lipids
Time Frame: three months
three months
change in fruit intake
Time Frame: three months
three months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospitalsenheden Vest

Investigators

  • Principal Investigator: Allan S Christensen, MHSc, The Department of Endocrinology and Metabolism, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (ACTUAL)

June 1, 2011

Study Completion (ACTUAL)

June 1, 2011

Study Registration Dates

First Submitted

November 9, 2009

First Submitted That Met QC Criteria

November 9, 2009

First Posted (ESTIMATE)

November 10, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 21, 2013

Last Update Submitted That Met QC Criteria

March 20, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20090183

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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