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.

Study Overview

• Status: Completed
• Conditions: Obesity; Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: High-protein diet; Dietary supplement: Standard diet

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Jeju, Korea, Republic of, 690-767
    • Jeju National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 79 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: High-protein diet	Dietary supplement: 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.; Other Names: A Jeju red horsehead fish-based meal
ACTIVE_COMPARATOR: Standard diet	Dietary supplement: Standard diet; The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.; Other Names: A mixed meal

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference in the iAUC for glucose 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 insulin 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 C-peptide 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 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

Collaborators and Investigators

• Sponsor: Jeju National University Hospital
• Investigators: Principal Investigator: Gwanpyo Koh, Professor, Jeju National University Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): April 1, 2013

Study Registration Dates

• First Submitted: August 25, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (ESTIMATE): September 5, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): April 2, 2015
• Last Update Submitted That Met QC Criteria: March 31, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Diet; Incretins; Fish Proteins; Gastrointestinal Hormones
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2012-06-007-002; C0038345 (OTHER_GRANT: The Small & Medium Business Administration)