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

Study Overview
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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.

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

Conditions
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Diabetes Mellitus, Obesity

Intervention / Treatment
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* Dietary Supplement: High-protein diet
* Dietary Supplement: Standard diet


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High-protein diet<br> | Dietary Supplement: High-protein diet<br>* 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.<br>* Other names: A Jeju red horsehead fish-based meal;|
| Active Comparator: Standard diet<br> | Dietary Supplement: Standard diet<br>* The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.<br>* Other names: A mixed meal;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups | 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 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups | 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 hours | 
| Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups | 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 hours | 
| Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups | 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 hours | 
| Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups | 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 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diet, Incretins, Gastrointestinal Hormones, Fish Proteins