Back to resultsPostprandial Effects of Milk and Milk Constituents
Primary Purpose
Hyperlipidemia, Inflammation
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Milk
Protein
Calcium
Control
Sponsored by
About this trial
This is an interventional prevention trial for Hyperlipidemia focused on measuring Milk, Postprandial hyperlipidemia, Postprandial inflammation, Overweight
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) above 27 kg/m2
Exclusion Criteria:
- Smoking
- Diabetes mellitus
- Cardiovascular diseases
- Familial hypercholesterolemia or lipid lowering medication
- Severe conditions that might interfere with the study outcomes, such as COPD, asthma, rheumatoid arthritis, etc.
- Unstable body weight
- Abuse of alcohol or drugs
- Participation in another biomedical study during the past 30 days
- Having donated blood during the past 30 days
Sites / Locations
- Maastricht University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Milk
Protein
Calcium
Control
Arm Description
500 mL low-fat milk added to high-fat meal
Milk protein in 500 mL water added to high-fat meal
Milk calcium in 500 mL water added to high-fat meal
Lactose in 500 mL water added to high-fat meal (control condition)
Outcomes
Primary Outcome Measures
Plasma inflammatory markers
Secondary Outcome Measures
Serum lipids
Full Information
NCT ID
NCT00917878
First Posted
June 8, 2009
Last Updated
April 25, 2018
Sponsor
Maastricht University Medical Center
Collaborators
Nederlandse Zuivel Organisatie
1. Study Identification
Unique Protocol Identification Number
NCT00917878
Brief Title
Postprandial Effects of Milk and Milk Constituents
Official Title
The Effects of Milk and Milk Constituents on Postprandial Inflammation in Overweight Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maastricht University Medical Center
Collaborators
Nederlandse Zuivel Organisatie
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine whether the addition of milk or the milk constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and inflammatory response.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperlipidemia, Inflammation
Keywords
Milk, Postprandial hyperlipidemia, Postprandial inflammation, Overweight
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Milk
Arm Type
Experimental
Arm Description
500 mL low-fat milk added to high-fat meal
Arm Title
Protein
Arm Type
Experimental
Arm Description
Milk protein in 500 mL water added to high-fat meal
Arm Title
Calcium
Arm Type
Experimental
Arm Description
Milk calcium in 500 mL water added to high-fat meal
Arm Title
Control
Arm Type
Experimental
Arm Description
Lactose in 500 mL water added to high-fat meal (control condition)
Intervention Type
Dietary Supplement
Intervention Name(s)
Milk
Intervention Description
500 mL low-fat milk added to high-fat meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Protein
Intervention Description
Milk protein in 500 mL water added to high-fat meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Calcium
Intervention Description
Milk calcium in 500 mL water added to high-fat meal
Intervention Type
Dietary Supplement
Intervention Name(s)
Control
Intervention Description
Lactose in 500 mL water added to high-fat meal
Primary Outcome Measure Information:
Title
Plasma inflammatory markers
Time Frame
6 h after meal
Secondary Outcome Measure Information:
Title
Serum lipids
Time Frame
6 h after meal
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Body mass index (BMI) above 27 kg/m2
Exclusion Criteria:
Smoking
Diabetes mellitus
Cardiovascular diseases
Familial hypercholesterolemia or lipid lowering medication
Severe conditions that might interfere with the study outcomes, such as COPD, asthma, rheumatoid arthritis, etc.
Unstable body weight
Abuse of alcohol or drugs
Participation in another biomedical study during the past 30 days
Having donated blood during the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald P Mensink, Prof. Dr. Ir.
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maastricht University Medical Center
City
Maastricht
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
Postprandial Effects of Milk and Milk Constituents
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