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)
Sponsor:
Information provided by (Responsible Party):
Allan Stubbe Christensen, Hospitalsenheden Vest
ClinicalTrials.gov Identifier:
NCT01010594
First received: November 9, 2009
Last updated: March 20, 2013
Last verified: March 2013

November 9, 2009
March 20, 2013
November 2009
June 2011   (final data collection date for primary outcome measure)
Change in Hba1c [ Time Frame: three months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01010594 on ClinicalTrials.gov Archive Site
  • change in bodyweight [ Time Frame: three months ] [ Designated as safety issue: No ]
  • change in serum lipids [ Time Frame: three months ] [ Designated as safety issue: No ]
  • change in fruit intake [ Time Frame: three months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Two Pieces of Fruit to Type 2 Diabetics?
Two Pieces of Fruit to Type 2 Diabetics?

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • 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 restricted
    Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.
    Intervention: Behavioral: dietary treatment
  • Active Comparator: Fruit ad libitum
    Type 2 diabetics are advised to eat at least two pieces of fruits daily
    Intervention: Behavioral: dietary treatment
Christensen AS, Viggers L, Hasselström K, Gregersen S. Effect of fruit restriction on glycemic control in patients with type 2 diabetes - a randomized trial. Nutr J. 2013 Mar 5;12:29. doi: 10.1186/1475-2891-12-29.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
64
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT01010594
M-20090183
Yes
Allan Stubbe Christensen, Hospitalsenheden Vest
Hospitalsenheden Vest
Not Provided
Principal Investigator: Allan S Christensen, MHSc The Department of Endocrinology and Metabolism, Aarhus University Hospital
Hospitalsenheden Vest
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP