Two Pieces of Fruit to Type 2 Diabetics?

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: dietary treatment

• Registration Number: NCT01010594
• Lead Sponsor: Hospitalsenheden Vest

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2009-11-09
• Study First Submitted QC: 2009-11-09
• Study First Posted: 2009-11-10
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-20
• Last Update Posted: 2013-03-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 64

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fruit restricted	dietary treatment	Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.
Fruit ad libitum	dietary treatment	Type 2 diabetics are advised to eat at least two pieces of fruits daily

Primary Outcome Measures

Name	Time	Method
Change in Hba1c	three months

Secondary Outcome Measures

Name	Time	Method
change in bodyweight	three months
change in serum lipids	three months
change in fruit intake	three months

Trial Locations

Locations (1)

Department of nutrition, Regional Hospital West Jutland; 🇩🇰 Holstebro, Denmark