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Completed

NCT Number: NCT01317524

The Effects of Homogenized and Unhomogenized Milk on Postprandial Metabolism in Healthy Overweight Men

The purpose of this study is to compare the effects of homogenized, unhomogenized and skimmed milk on postprandial metabolism in healthy overweight men

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Key information

Conditions

Hyperlipidemias Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Body Weight Cardiovascular Diseases Dyslipidemias Inflammation Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Homogenized milk

Dietary Supplement

900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread

Unhomogenized milk

Dietary Supplement

900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread

Skimmed Milk

Dietary Supplement

900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread

Primary outcomes

  1. Incremental Area Under the triacylglycerol Curve

    Time frame: during 8 hours after meal consumption

Secondary outcomes

  1. Plasma inflammatory markers

    Time frame: during 8 hours after meal consumption

  2. Markers of endothelial activation

    Time frame: during 8 hours after meal consumption

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Dutch Dairy Association (NZO)

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 17, 2011
Registry last updated
Dec 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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