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

This study is currently recruiting participants.

Verified by Aarhus University Hospital, March 2009

First Received: March 17, 2009 No Changes Posted

Sponsors and Collaborators:	Aarhus University Hospital DanORC Nordic Centre of Excellence
Information provided by:	Aarhus University Hospital
ClinicalTrials.gov Identifier:	NCT00863564

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

MedlinePlus related topics: Dietary Proteins Dietary Supplements Diets Obesity

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Subject), Uncontrolled, Crossover Assignment, Efficacy Study
Official Title:	Acute Effects of Dietary Proteins on Postprandial Lipemia, Incretin Responses and Subclinical Inflammation in Obese Subjects

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
Estimated Study Completion Date:	January 2010
Estimated Primary Completion Date:	January 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Whey Isolate: Active Comparator	Dietary Supplement: Whey Isolate
Caseine: Active Comparator	Dietary Supplement: Caseine
Cod: Active Comparator	Dietary Supplement: Cod
Gluten: Active Comparator	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

Contacts

Contact: J. Holmer-Jensen, MD

holmer-jensen@ki.au.dk

Locations

Denmark
Department of Clinical Nutrion	Recruiting
Aarhus, Denmark, 8000
Contact: J Holmer, MD holmer-jensen@ki.au.dk

Sponsors and Collaborators

Aarhus University Hospital

DanORC

Nordic Centre of Excellence

Investigators

Principal Investigator:

K Hermansen, Professor, MD

Department of Endocrinology and Metabolism, Aarhus University Hospital

More Information

No publications provided

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

Keywords provided by Aarhus University Hospital:

Postprandial Period
Postprandial Lipaemia
Incretins
Subclinical Inflammation
Obesity

Atherosclerosis
Triglyceride
Lipoproteins
Postprandial inflammation

Study placed in the following topic categories:

Atherosclerosis
Arterial Occlusive Diseases
Obesity
Hyperlipidemias
Metabolic Diseases
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Overweight
Arteriosclerosis

Hormones
Inflammation
Body Weight
Signs and Symptoms
Incretins
Nutrition Disorders
Overnutrition
Metabolic Disorder
Dyslipidemias
Lipid Metabolism Disorders

Additional relevant MeSH terms:

Atherosclerosis
Arterial Occlusive Diseases
Obesity
Hyperlipidemias
Metabolic Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Vascular Diseases
Overweight
Arteriosclerosis
Hormones

Pharmacologic Actions
Inflammation
Body Weight
Signs and Symptoms
Pathologic Processes
Incretins
Nutrition Disorders
Cardiovascular Diseases
Overnutrition
Dyslipidemias
Lipid Metabolism Disorders

ClinicalTrials.gov processed this record on May 07, 2009