Two Pieces of Fruit to Type 2 Diabetics?

Hospitalsenheden Vest

Status: Terminated

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: dietary treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT01010594

M-20090183

Details and patient eligibility

About

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.

Enrollment: 64 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Fruit restricted

Active Comparator group

Description:

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

Treatment:

Behavioral: dietary treatment

Behavioral: dietary treatment

Fruit ad libitum

Active Comparator group

Description:

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

Treatment:

Behavioral: dietary treatment

Behavioral: dietary treatment