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Two Pieces of Fruit to Type 2 Diabetics?

This study has been terminated.
(PI changed job and project was not economically viable and therefor terminated)
Information provided by (Responsible Party):
Allan Stubbe Christensen, Hospitalsenheden Vest Identifier:
First received: November 9, 2009
Last updated: March 20, 2013
Last verified: March 2013

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.

Condition Intervention
Diabetes Mellitus, Type 2
Behavioral: dietary treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Two Pieces of Fruit to Type 2 Diabetics?

Further study details as provided by Allan Stubbe Christensen, Hospitalsenheden Vest:

Primary Outcome Measures:
  • Change in Hba1c [ Time Frame: three months ]

Secondary Outcome Measures:
  • change in bodyweight [ Time Frame: three months ]
  • change in serum lipids [ Time Frame: three months ]
  • change in fruit intake [ Time Frame: three months ]

Enrollment: 64
Study Start Date: November 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01010594

Department of nutrition, Regional Hospital West Jutland
Holstebro, Denmark, 7500
Sponsors and Collaborators
Hospitalsenheden Vest
Principal Investigator: Allan S Christensen, MHSc The Department of Endocrinology and Metabolism, Aarhus University Hospital
  More Information

Responsible Party: Allan Stubbe Christensen, MHSc, RD, Hospitalsenheden Vest Identifier: NCT01010594     History of Changes
Other Study ID Numbers: M-20090183
Study First Received: November 9, 2009
Last Updated: March 20, 2013

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases processed this record on May 25, 2017