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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00917878
Other study ID # MEC 08-3-096
Secondary ID
Status Completed
Phase N/A
First received June 8, 2009
Last updated April 25, 2018
Start date March 2009
Est. completion date July 2009

Study information

Verified date September 2009
Source Maastricht University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date July 2009
Est. primary completion date July 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Intervention

Dietary Supplement:
Milk
500 mL low-fat milk added to high-fat meal
Protein
Milk protein in 500 mL water added to high-fat meal
Calcium
Milk calcium in 500 mL water added to high-fat meal
Control
Lactose in 500 mL water added to high-fat meal

Locations

Country Name City State
Netherlands Maastricht University Medical Center Maastricht

Sponsors (2)

Lead Sponsor Collaborator
Maastricht University Medical Center Nederlandse Zuivel Organisatie

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Plasma inflammatory markers 6 h after meal
Secondary Serum lipids 6 h after meal
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