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Completed

NCT Number: NCT01678742

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

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

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Key information

Conditions

Diabetes Mellitus Body Weight Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeju National University Hospital

Jeju City, 690-767, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-protein diet

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.

Other names: A Jeju red horsehead fish-based meal

Standard diet

Dietary Supplement

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

Other names: A mixed meal

Primary outcomes

  1. Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

Secondary outcomes

  1. Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

  2. Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

  3. Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

  4. Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

Other outcomes

  1. Difference in the iAUC for glucose after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

  2. Difference in the iAUC for insulin after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

  3. Difference in the iAUC for C-peptide after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

  4. Difference in the iAUC for glucagon after food ingestion between high-protein and standard diet groups

    Time frame: 3 hours

    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.

Sponsors and collaborators

Lead sponsor

Jeju National University Hospital

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Sep 5, 2012
Registry last updated
Apr 2, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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