NCT00917878

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2009

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

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

April 27, 2018

Status Verified

September 1, 2009

Enrollment Period

4 months

First QC Date

June 8, 2009

Last Update Submit

April 25, 2018

Conditions

HyperlipidemiaInflammation

Keywords

MilkPostprandial hyperlipidemiaPostprandial inflammationOverweight

Outcome Measures

Primary Outcomes (1)

  • Plasma inflammatory markers

    6 h after meal

Secondary Outcomes (1)

  • Serum lipids

    6 h after meal

Study Arms (4)

Milk

EXPERIMENTAL

500 mL low-fat milk added to high-fat meal

Dietary Supplement: Milk

Protein

EXPERIMENTAL

Milk protein in 500 mL water added to high-fat meal

Dietary Supplement: Protein

Calcium

EXPERIMENTAL

Milk calcium in 500 mL water added to high-fat meal

Dietary Supplement: Calcium

Control

EXPERIMENTAL

Lactose in 500 mL water added to high-fat meal (control condition)

Dietary Supplement: Control

Interventions

MilkDIETARY_SUPPLEMENT

500 mL low-fat milk added to high-fat meal

Milk
ProteinDIETARY_SUPPLEMENT

Milk protein in 500 mL water added to high-fat meal

Protein
CalciumDIETARY_SUPPLEMENT

Milk calcium in 500 mL water added to high-fat meal

Calcium
ControlDIETARY_SUPPLEMENT

Lactose in 500 mL water added to high-fat meal

Control

Eligibility Criteria

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

You may qualify if:

  • Body mass index (BMI) above 27 kg/m2

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Center

Maastricht, Netherlands

Location

MeSH Terms

Conditions

HyperlipidemiasInflammationOverweight

Interventions

MilkProteinsCalcium

Condition Hierarchy (Ancestors)

DyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOvernutritionNutrition DisordersBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaDairy ProductsFoodFood and BeveragesAmino Acids, Peptides, and ProteinsMetals, Alkaline EarthElementsInorganic ChemicalsMetalsBlood Coagulation FactorsBiological Factors

Study Officials

  • Ronald P Mensink, Prof. Dr. Ir.

    Maastricht University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2009

First Posted

June 10, 2009

Study Start

March 1, 2009

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

April 27, 2018

Record last verified: 2009-09

Locations

NL(1)