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

This study is currently recruiting participants.
Verified September 2012 by Jeju National University Hospital
Sponsor:
Information provided by (Responsible Party):
Gwanpyo Koh, Jeju National University Hospital
ClinicalTrials.gov Identifier:
NCT01678742
First received: August 25, 2012
Last updated: September 8, 2012
Last verified: September 2012
History of Changes
  Purpose

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


Condition Intervention
Diabetes Mellitus
Obesity
 Dietary Supplement: High-protein diet
Dietary Supplement: Standard diet

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Obesity
U.S. FDA Resources

Further study details as provided by Jeju National University Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 ghrelin after food ingestion between high-protein and standard diet groups [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Difference in the iAUC for glucose after food ingestion between high-protein and standard diet groups [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 insulin after food ingestion between high-protein and standard diet groups [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 C-peptide after food ingestion between high-protein and standard diet groups [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 after food ingestion between high-protein and standard diet groups [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.


Estimated Enrollment: 36
Study Start Date: August 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: A mixed meal

  Eligibility

Ages Eligible for Study:   20 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678742

Contacts
Contact: Okkyeong Hwang, CRC 82-10-4484-5251 okkyeong@gmail.com

Locations
Korea, Republic of
Jeju National University Hospital Recruiting
Jeju, Korea, Republic of, 690-767
Contact: Okkyeong Hwang, CRC     82-10-4484-5251     okkyeong@gmail.com    
Contact: Sang Ah Lee, Professor     82-10-3691-3304     sahe7@hanmail.net    
Principal Investigator: Gwanpyo Koh, Professor            
Sub-Investigator: Sang Ah Lee, Professor            
Sponsors and Collaborators
Jeju National University Hospital
Investigators
Principal Investigator: Gwanpyo Koh, Professor Jeju National University Hospital
  More Information

No publications provided

Responsible Party: Gwanpyo Koh, Associate professor, Jeju National University Hospital
ClinicalTrials.gov Identifier: NCT01678742     History of Changes
Other Study ID Numbers: 2012-06-007-002, C0038345
Study First Received: August 25, 2012
Last Updated: September 8, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Jeju National University Hospital:
Diet
Incretins
Gastrointestinal Hormones
Fish Proteins

Additional relevant MeSH terms:
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
 Body Weight
Signs and Symptoms
Hormones
Incretins
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013