NCT01317524

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2011

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 17, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

December 1, 2011

Status Verified

November 1, 2011

Enrollment Period

4 months

First QC Date

March 16, 2011

Last Update Submit

November 30, 2011

Conditions

HyperlipidemiasInflammationAtherosclerosis

Keywords

MilkHomogenizationPostprandial hyperlipidemiaPostprandial inflammationOverweight

Outcome Measures

Primary Outcomes (1)

  • Incremental Area Under the triacylglycerol Curve

    during 8 hours after meal consumption

Secondary Outcomes (2)

  • Plasma inflammatory markers

    during 8 hours after meal consumption

  • Markers of endothelial activation

    during 8 hours after meal consumption

Study Arms (3)

Homogenized Milk

EXPERIMENTAL

900 mL homogenized milk is consumed within a mixed meal

Dietary Supplement: Homogenized milk

Unhomogenized Milk

EXPERIMENTAL

900 mL unhomogenized milk is consumed within a mixed meal

Dietary Supplement: Unhomogenized milk

Skimmed Milk

EXPERIMENTAL

900 mL skimmed milk and 44 g of butter are consumed within a mixed meal

Dietary Supplement: Skimmed Milk

Interventions

Homogenized milkDIETARY_SUPPLEMENT

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

Homogenized Milk
Unhomogenized milkDIETARY_SUPPLEMENT

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

Unhomogenized Milk
Skimmed MilkDIETARY_SUPPLEMENT

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

Skimmed Milk

Eligibility Criteria

Age18 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • men
  • aged between 18 and 70 years
  • Quetelet index between 25 - 30 kg/m2
  • mean serum triacylglycerol (≤1.7 mmol/L (31))

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Limburg, 6200 MD, Netherlands

Location

MeSH Terms

Conditions

HyperlipidemiasInflammationAtherosclerosisOverweight

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Study Officials

  • Ronald P Mensink, PhD.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 16, 2011

First Posted

March 17, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

December 1, 2011

Record last verified: 2011-11

Locations

NL(1)