Two Pieces of Fruit to Type 2 Diabetics?

NCT ID: NCT01010594

Last Updated: 2013-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2011-06-30

Brief Summary

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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

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fruit restricted

Type 2 diabetics are advised to restrict their fruit intake to two pieces or less daily.

Group Type ACTIVE_COMPARATOR

dietary treatment

Intervention Type BEHAVIORAL

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

Fruit ad libitum

Type 2 diabetics are advised to eat at least two pieces of fruits daily

Group Type ACTIVE_COMPARATOR

dietary treatment

Intervention Type BEHAVIORAL

A standard dietary treatment.

Interventions

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dietary treatment

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

Intervention Type BEHAVIORAL

dietary treatment

A standard dietary treatment.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospitalsenheden Vest

OTHER

Sponsor Role lead

Responsible Party

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Allan Stubbe Christensen

MHSc, RD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Allan S Christensen, MHSc

Role: PRINCIPAL_INVESTIGATOR

The Department of Endocrinology and Metabolism, Aarhus University Hospital

Locations

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Department of nutrition, Regional Hospital West Jutland

Holstebro, Holstebro, Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type RESULT
PMID: 23497350 (View on PubMed)

Other Identifiers

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M-20090183

Identifier Type: -

Identifier Source: org_study_id

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