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

Not Applicable

Completed

• Conditions: Diabetes Mellitus; Obesity
• Interventions: Dietary Supplement: High-protein diet; Dietary Supplement: Standard diet

• Registration Number: NCT01678742
• Lead Sponsor: Jeju National University Hospital

Brief Summary

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

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-25
• Study First Submitted QC: 2012-08-30
• Study First Posted: 2012-09-05
• Primary Completion: 2013-04
• Study Completion: 2013-04
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-31
• Last Update Posted: 2015-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-protein diet	High-protein diet	-
Standard diet	Standard diet	-

Primary Outcome Measures

Name	Time	Method
Difference in the incremental area under the curve (iAUC) for peptide YY (PYY) after food ingestion between high-protein and standard diet groups	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 Outcome Measures

Name	Time	Method
Difference in the iAUC for ghrelin after food ingestion between high-protein and standard diet groups	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.
Difference in the iAUC for glucagon-like peptide 1 (GLP-1) after food ingestion between high-protein and standard diet groups	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.
Difference in the iAUC for glucose-dependent insulinotropic polypeptide (GIP) after food ingestion between high-protein and standard diet groups	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.
Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups	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.

Trial Locations

Locations (1)

Jeju National University Hospital; 🇰🇷 Jeju, Korea, Republic of