The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men
This study has been completed.
Sponsor:
Maastricht University Medical Center
Collaborator:
Dutch Dairy Association (NZO)
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01317524
First received: March 16, 2011
Last updated: November 30, 2011
Last verified: November 2011
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Purpose
The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men
| Condition | Intervention |
|---|---|
|
Hyperlipidemias Inflammation Atherosclerosis |
Dietary Supplement: Homogenized milk Dietary Supplement: Unhomogenized milk Dietary Supplement: Skimmed Milk |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
| Official Title: | The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men |
Resource links provided by NLM:
Further study details as provided by Maastricht University Medical Center:
Primary Outcome Measures:
- Incremental Area Under the triacylglycerol Curve [ Time Frame: during 8 hours after meal consumption ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Plasma inflammatory markers [ Time Frame: during 8 hours after meal consumption ] [ Designated as safety issue: No ]
- Markers of endothelial activation [ Time Frame: during 8 hours after meal consumption ] [ Designated as safety issue: No ]
| Enrollment: | 18 |
| Study Start Date: | February 2011 |
| Study Completion Date: | June 2011 |
| Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Homogenized Milk
900 mL homogenized milk is consumed within a mixed meal
|
Dietary Supplement: Homogenized milk
900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
|
|
Experimental: Unhomogenized Milk
900 mL unhomogenized milk is consumed within a mixed meal
|
Dietary Supplement: Unhomogenized milk
900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
|
|
Experimental: Skimmed Milk
900 mL skimmed milk and 44 g of butter are consumed within a mixed meal
|
Dietary Supplement: Skimmed Milk
900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- men
- aged between 18 and 70 years
- Quetelet index between 25 - 30 kg/m2
- mean serum triacylglycerol (≤1.7 mmol/L (31))
Exclusion Criteria:
- women
- indication for treatment with cholesterol-lowering drugs according to the Dutch Cholesterol Consensus (32)
- lactose intolerance
- current smoker
- familial hypercholesterolemia
- abuse of drugs
- more than 21 alcoholic consumptions per week
- no stable body weight (weight gain or loss < 3 kg in the past three months)
- use of medication or a diet known to affect serum lipid or glucose metabolism
- severe medical conditions that might interfere with the study, such as epilepsy, asthma, chronic obstructive pulmonary disease, inflammatory bowel diseases and rheumatoid arthritis.
- active cardiovascular disease like congestive heart failure or recent (<6 months) event (acute myocardial infarction, cerebro vascular accident)
- use of an investigational product within the previous 1 month
- not willing to stop the consumption of vitamin supplements, fish oil capsules or products rich in plant stanol or sterol esters 3 weeks before the start of the study
- not willing to give up being a blood donor (or having donated blood) from 8 weeks before the start of the study and during the study
- difficult venipuncture as evidenced during the screening visits
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317524
Locations
| Netherlands | |
| Maastricht University Medical Center | |
| Maastricht, Limburg, Netherlands, 6200 MD | |
Sponsors and Collaborators
Maastricht University Medical Center
Dutch Dairy Association (NZO)
Investigators
| Principal Investigator: | Ronald P Mensink, PhD. | Maastricht University Medical Center |
More Information
No publications provided
| Responsible Party: | Maastricht University Medical Center |
| ClinicalTrials.gov Identifier: | NCT01317524 History of Changes |
| Other Study ID Numbers: | MEC 10-3-089 |
| Study First Received: | March 16, 2011 |
| Last Updated: | November 30, 2011 |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Maastricht University Medical Center:
|
Milk Homogenization Postprandial hyperlipidemia Postprandial inflammation Overweight |
Additional relevant MeSH terms:
|
Atherosclerosis Hyperlipidemias Inflammation Overweight Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases |
Cardiovascular Diseases Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Pathologic Processes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013