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Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects

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ClinicalTrials.gov Identifier: NCT00863564
Recruitment Status : Completed
First Posted : March 18, 2009
Last Update Posted : November 10, 2009
Sponsor:
Collaborators:
The Danish Obesity Research Centre
Nordic Centre of Excellence
Information provided by:
Aarhus University Hospital

Tracking Information
First Submitted Date  ICMJE March 17, 2009
First Posted Date  ICMJE March 18, 2009
Last Update Posted Date November 10, 2009
Study Start Date  ICMJE March 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
Triglyceride [ Time Frame: 0h- 2h- 4h- 6h- 8h postprandial ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 17, 2009)
  • Incretins [ Time Frame: 0h -1h -2h -4h -6h -8h Postprandial ]
  • Inflammatory markers [ Time Frame: 0h- 1h- 2h- 4h- 6h- 8h postprandial ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects
Official Title  ICMJE Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects
Brief Summary

The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal.

Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Condition  ICMJE
  • Obesity
  • Postprandial Lipemia
  • Atherosclerosis
  • Inflammation
  • Postprandial Incretins
Intervention  ICMJE
  • Dietary Supplement: Caseine
  • Dietary Supplement: Cod
  • Dietary Supplement: Gluten
  • Dietary Supplement: Whey Isolate
Study Arms  ICMJE
  • Active Comparator: Whey Isolate
    Intervention: Dietary Supplement: Whey Isolate
  • Active Comparator: Caseine
    Intervention: Dietary Supplement: Caseine
  • Active Comparator: Cod
    Intervention: Dietary Supplement: Cod
  • Active Comparator: Gluten
    Intervention: Dietary Supplement: Gluten
Publications * Holmer-Jensen J, Karhu T, Mortensen LS, Pedersen SB, Herzig KH, Hermansen K. Differential effects of dietary protein sources on postprandial low-grade inflammation after a single high fat meal in obese non-diabetic subjects. Nutr J. 2011 Oct 19;10:115. doi: 10.1186/1475-2891-10-115.

*   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
Estimated Enrollment  ICMJE
 (submitted: March 17, 2009)
12
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2009
Actual Primary Completion Date October 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • BMI > 30 kg/m2 & < 45 kg/m2

Exclusion Criteria:

  • Diabetes
  • Lipid lowering drugs
  • Liver-, Kidney- and/or Heart Disease
  • Serious Hypertension (160/110)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Denmark
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00863564
Other Study ID Numbers  ICMJE CERN-PPL-JHJ-5a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kjeld Hermansen, Professor, Chief Physician, MD, Dr.Med.Sci, Department of Endocrinology And Metabolism, Aarhus University Hospital
Study Sponsor  ICMJE Aarhus University Hospital
Collaborators  ICMJE
  • The Danish Obesity Research Centre
  • Nordic Centre of Excellence
Investigators  ICMJE
Principal Investigator: K Hermansen, Professor, MD Department of Endocrinology and Metabolism, Aarhus University Hospital
PRS Account Aarhus University Hospital
Verification Date November 2009

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