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

This study has been completed.
Sponsor:
Collaborators:
The Danish Obesity Research Centre
Nordic Centre of Excellence
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00863564
First received: March 17, 2009
Last updated: November 9, 2009
Last verified: November 2009
History of Changes
  Purpose

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.


Condition Intervention
Obesity
Postprandial Lipemia
Atherosclerosis
Inflammation
Postprandial Incretins
 Dietary Supplement: Caseine
Dietary Supplement: Cod
Dietary Supplement: Gluten
Dietary Supplement: Whey Isolate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • Triglyceride [ Time Frame: 0h- 2h- 4h- 6h- 8h postprandial ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Incretins [ Time Frame: 0h -1h -2h -4h -6h -8h Postprandial ] [ Designated as safety issue: No ]
  • Inflammatory markers [ Time Frame: 0h- 1h- 2h- 4h- 6h- 8h postprandial ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: March 2009
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Whey Isolate Dietary Supplement: Whey Isolate
Active Comparator: Caseine Dietary Supplement: Caseine
Active Comparator: Cod Dietary Supplement: Cod
Active Comparator: Gluten Dietary Supplement: Gluten

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00863564

Locations
Denmark
Department of Clinical Nutrion
Aarhus, Denmark, 8000
Sponsors and Collaborators
Aarhus University Hospital
The Danish Obesity Research Centre
Nordic Centre of Excellence
Investigators
Principal Investigator: K Hermansen, Professor, MD Department of Endocrinology and Metabolism, Aarhus University Hospital
  More Information

No publications provided by Aarhus University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kjeld Hermansen, Professor, Chief Physician, MD, Dr.Med.Sci, Department of Endocrinology And Metabolism, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00863564     History of Changes
Other Study ID Numbers: CERN-PPL-JHJ-5a
Study First Received: March 17, 2009
Last Updated: November 9, 2009
Health Authority: Denmark: Ethics Committee

Keywords provided by Aarhus University Hospital:
Postprandial Period
Postprandial Lipaemia
Incretins
Subclinical Inflammation
Obesity
 Atherosclerosis
Triglyceride
Lipoproteins
Postprandial inflammation

Additional relevant MeSH terms:
Atherosclerosis
Hyperlipidemias
Inflammation
Obesity
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
 Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013