Back to resultsTwo Pieces of Fruit to Type 2 Diabetics?
Primary Purpose
Diabetes Mellitus, Type 2
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
dietary treatment
dietary treatment
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2
Eligibility Criteria
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
Sites / Locations
- Department of nutrition, Regional Hospital West Jutland
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fruit restricted
Fruit ad libitum
Arm Description
Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.
Type 2 diabetics are advised to eat at least two pieces of fruits daily
Outcomes
Primary Outcome Measures
Change in Hba1c
Secondary Outcome Measures
change in bodyweight
change in serum lipids
change in fruit intake
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01010594
Brief Title
Two Pieces of Fruit to Type 2 Diabetics?
Official Title
Two Pieces of Fruit to Type 2 Diabetics?
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
PI changed job and project was not economically viable and therefor terminated
Study Start Date
November 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospitalsenheden Vest
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fruit restricted
Arm Type
Active Comparator
Arm Description
Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.
Arm Title
Fruit ad libitum
Arm Type
Active Comparator
Arm Description
Type 2 diabetics are advised to eat at least two pieces of fruits daily
Intervention Type
Behavioral
Intervention Name(s)
dietary treatment
Intervention Description
A standard dietary treatment except that they are advised to restrict their fruit intake.
Intervention Type
Behavioral
Intervention Name(s)
dietary treatment
Intervention Description
A standard dietary treatment.
Primary Outcome Measure Information:
Title
Change in Hba1c
Time Frame
three months
Secondary Outcome Measure Information:
Title
change in bodyweight
Time Frame
three months
Title
change in serum lipids
Time Frame
three months
Title
change in fruit intake
Time Frame
three months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allan S Christensen, MHSc
Organizational Affiliation
The Department of Endocrinology and Metabolism, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of nutrition, Regional Hospital West Jutland
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
23497350
Citation
Christensen AS, Viggers L, Hasselstrom 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.
Results Reference
result
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Two Pieces of Fruit to Type 2 Diabetics?
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