Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients

NCT ID: NCT01678742

Last Updated: 2015-04-02

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

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-04-30

Brief Summary

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The aim of our study is to investigate the effects of high-protein diet on satiety and incretin hormones in patients with diabetes.

Detailed Description

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Conditions

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Diabetes Mellitus Obesity

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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High-protein diet

Group Type EXPERIMENTAL

High-protein diet

Intervention Type DIETARY_SUPPLEMENT

The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal.

A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea.

Standard diet

Group Type ACTIVE_COMPARATOR

Standard diet

Intervention Type DIETARY_SUPPLEMENT

The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.

Interventions

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High-protein diet

The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal.

A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea.

Intervention Type DIETARY_SUPPLEMENT

Standard diet

The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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A Jeju red horsehead fish-based meal A mixed meal

Eligibility Criteria

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Inclusion Criteria

* Diabetes mellitus
* Subjects signed a written informed consent form

Exclusion Criteria

* Liver cirrhosis
* Chronic renal disease (serum creatinine \> 2mg/dL)
* Severe congestive heart failure
* Significant infectious or inflammatory diseases
* intractable malignant neoplasm
* Pregnancy
Minimum Eligible Age

20 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jeju National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Gwanpyo Koh

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gwanpyo Koh, Professor

Role: PRINCIPAL_INVESTIGATOR

Jeju National University Hospital

Locations

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Jeju National University Hospital

Jeju City, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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C0038345

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012-06-007-002

Identifier Type: -

Identifier Source: org_study_id

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