Study Stopped
PI changed job and project was not economically viable and therefor terminated
Two Pieces of Fruit to Type 2 Diabetics?
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes-mellitus-type-2
Started Nov 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 9, 2009
CompletedFirst Posted
Study publicly available on registry
November 10, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedMarch 21, 2013
March 1, 2013
1.6 years
November 9, 2009
March 20, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Hba1c
three months
Secondary Outcomes (3)
change in bodyweight
three months
change in serum lipids
three months
change in fruit intake
three months
Study Arms (2)
Fruit restricted
ACTIVE COMPARATORType 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.
Fruit ad libitum
ACTIVE COMPARATORType 2 diabetics are advised to eat at least two pieces of fruits daily
Interventions
A standard dietary treatment except that they are advised to restrict their fruit intake.
Eligibility Criteria
You may qualify if:
- patients refered from a general practitioner
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of nutrition, Regional Hospital West Jutland
Holstebro, Holstebro, 7500, Denmark
Related Publications (1)
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.
PMID: 23497350RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Allan S Christensen, MHSc
The Department of Endocrinology and Metabolism, Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MHSc, RD
Study Record Dates
First Submitted
November 9, 2009
First Posted
November 10, 2009
Study Start
November 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
March 21, 2013
Record last verified: 2013-03