Two Pieces of Fruit to Type 2 Diabetics?

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Two Pieces of Fruit to Type 2 Diabetics?

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01010594
• Other study ID #: M-20090183
• Status: Terminated
• Phase: N/A
• First received: November 9, 2009
• Last updated: March 20, 2013
• Start date: November 2009
• Est. completion date: June 2011

Study information

• Verified date: March 2013
• Source: Hospitalsenheden Vest
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• dietary treatment
A standard dietary treatment except that they are advised to restrict their fruit intake.
• dietary treatment
A standard dietary treatment.

Locations

Country	Name	City	State
Denmark	Department of nutrition, Regional Hospital West Jutland	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
Hospitalsenheden Vest

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hba1c		three months	No
Secondary	change in bodyweight		three months	No
Secondary	change in serum lipids		three months	No
Secondary	change in fruit intake		three months	No