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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678742
Recruitment Status : Completed
First Posted : September 5, 2012
Last Update Posted : April 2, 2015
Sponsor:
Information provided by (Responsible Party):
Gwanpyo Koh, Jeju National University Hospital

Tracking Information
First Submitted Date  ICMJE August 25, 2012
First Posted Date  ICMJE September 5, 2012
Last Update Posted Date April 2, 2015
Study Start Date  ICMJE August 2012
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
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 ]
Blood samples were drawn before the test meal (time 0) and at 30, 60, 90, 120, and 180 min after the test meal commenced.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2012)
  • Difference in the iAUC for cholecystokinin (CCK) after food ingestion between high-protein and standard diet groups [ Time Frame: 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 ghrelin after food ingestion between high-protein and standard diet groups [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 30, 2012)
  • Difference in the iAUC for glucose after food ingestion between high-protein and standard diet groups [ Time Frame: 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 insulin after food ingestion between high-protein and standard diet groups [ Time Frame: 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 C-peptide after food ingestion between high-protein and standard diet groups [ Time Frame: 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 after food ingestion between high-protein and standard diet groups [ Time Frame: 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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients
Official Title  ICMJE Effects of Jeju Red Horsehead Fish-based, High Protein Diet on Satiety and Incretin Hormones in Diabetes Patients
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus
  • Obesity
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • Experimental: High-protein diet
    Intervention: Dietary Supplement: High-protein diet
  • Active Comparator: Standard diet
    Intervention: Dietary Supplement: Standard diet
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 31, 2015)
40
Original Estimated Enrollment  ICMJE
 (submitted: August 30, 2012)
36
Actual Study Completion Date  ICMJE April 2013
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01678742
Other Study ID Numbers  ICMJE 2012-06-007-002
C0038345 ( Other Grant/Funding Number: The Small & Medium Business Administration )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gwanpyo Koh, Jeju National University Hospital
Study Sponsor  ICMJE Jeju National University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gwanpyo Koh, Professor Jeju National University Hospital
PRS Account Jeju National University Hospital
Verification Date March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP