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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678742
• Other study ID #: 2012-06-007-002
• Secondary ID: C0038345
• Status: Completed
• Phase: N/A
• First received: August 25, 2012
• Last updated: March 31, 2015
• Start date: August 2012
• Est. completion date: April 2013

Study information

• Verified date: March 2015
• Source: Jeju National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Obesity

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jeju National University Hospital	Jeju

Sponsors (1)

Lead Sponsor	Collaborator
Jeju National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	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	No
Other	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	No
Other	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	No
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No