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Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects

Primary Purpose

Postprandial Lipaemia, Postprandial Incretins, Postprandial Inflammation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Casein
Whey Isolate
Whey Hydrolysate
Alphalact-Albumin
Sponsored by
Aarhus University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postprandial Lipaemia focused on measuring Postprandial Period, Postprandial Lipaemia, Incretins, Subclinical Inflammation, Obesity, Atherosclerosis, Triglyceride, Lipoproteins

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Department of Clinical Nutrion

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Casein

Whey Isolate

Whey Hydrolysate

Alphalact-Albumin

Arm Description

Outcomes

Primary Outcome Measures

Triglyceride

Secondary Outcome Measures

Incretins

Full Information

First Posted
December 16, 2008
Last Updated
November 9, 2009
Sponsor
Aarhus University Hospital
Collaborators
The Danish Obesity Research Centre, Nordic Centre of Excellence, Arla Foods
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1. Study Identification

Unique Protocol Identification Number
NCT00809874
Brief Title
Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects
Official Title
Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
December 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Aarhus University Hospital
Collaborators
The Danish Obesity Research Centre, Nordic Centre of Excellence, Arla Foods

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postprandial Lipaemia, Postprandial Incretins, Postprandial Inflammation
Keywords
Postprandial Period, Postprandial Lipaemia, Incretins, Subclinical Inflammation, Obesity, Atherosclerosis, Triglyceride, Lipoproteins

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Casein
Arm Type
Active Comparator
Arm Title
Whey Isolate
Arm Type
Active Comparator
Arm Title
Whey Hydrolysate
Arm Type
Active Comparator
Arm Title
Alphalact-Albumin
Arm Type
Active Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Casein
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Isolate
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Hydrolysate
Intervention Type
Dietary Supplement
Intervention Name(s)
Alphalact-Albumin
Primary Outcome Measure Information:
Title
Triglyceride
Time Frame
0h- 1h- 2h- 4h- 6h- 7h- 8h postprandial
Secondary Outcome Measure Information:
Title
Incretins
Time Frame
0h -1h -2h -4h -6h -7h -8h Postprandial

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
K Hermansen, Professor, MD
Organizational Affiliation
Department of Endocrinology and Metabolism, Aarhus University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Clinical Nutrion
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

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Effects of Dietary Proteins on Postprandial Lipaemia and Incretin Responses in Obese Subjects

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