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

November 9, 2009 updated by: Aarhus University Hospital

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Aarhus, Denmark, 8000
        • Department of Clinical Nutrion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Cod
Active Comparator: Gluten
Active Comparator: Whey Isolate
Active Comparator: Caseine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Triglyceride
Time Frame: 0h- 2h- 4h- 6h- 8h postprandial
0h- 2h- 4h- 6h- 8h postprandial

Secondary Outcome Measures

Outcome Measure
Time Frame
Incretins
Time Frame: 0h -1h -2h -4h -6h -8h Postprandial
0h -1h -2h -4h -6h -8h Postprandial
Inflammatory markers
Time Frame: 0h- 1h- 2h- 4h- 6h- 8h postprandial
0h- 1h- 2h- 4h- 6h- 8h postprandial

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: K Hermansen, Professor, MD, Department of Endocrinology and Metabolism, Aarhus University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

October 1, 2009

Study Completion (Actual)

October 1, 2009

Study Registration Dates

First Submitted

March 17, 2009

First Submitted That Met QC Criteria

March 17, 2009

First Posted (Estimate)

March 18, 2009

Study Record Updates

Last Update Posted (Estimate)

November 10, 2009

Last Update Submitted That Met QC Criteria

November 9, 2009

Last Verified

November 1, 2009

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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