NCT00809874

Brief Summary

The purpose of this study is to determine the effects of dietary protein on blood lipids and gut hormones after a fat-rich meal. Hypothesis: Certain dietary proteins reduce the amount of fat circulating in the blood stream following a fat rich meal. The effect is dependant of both the quality and the quantity of protein ingested.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2008

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, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 17, 2008

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

Enrollment Period

10 months

First QC Date

December 16, 2008

Last Update Submit

November 9, 2009

Conditions

Postprandial LipaemiaPostprandial IncretinsPostprandial Inflammation

Keywords

Postprandial PeriodPostprandial LipaemiaIncretinsSubclinical InflammationObesityAtherosclerosisTriglycerideLipoproteins

Outcome Measures

Primary Outcomes (1)

  • Triglyceride

    0h- 1h- 2h- 4h- 6h- 7h- 8h postprandial

Secondary Outcomes (1)

  • Incretins

    0h -1h -2h -4h -6h -7h -8h Postprandial

Study Arms (4)

Casein

ACTIVE COMPARATOR
Dietary Supplement: Casein

Whey Isolate

ACTIVE COMPARATOR
Dietary Supplement: Whey Isolate

Whey Hydrolysate

ACTIVE COMPARATOR
Dietary Supplement: Whey Hydrolysate

Alphalact-Albumin

ACTIVE COMPARATOR
Dietary Supplement: Alphalact-Albumin

Interventions

CaseinDIETARY_SUPPLEMENT
Casein
Whey IsolateDIETARY_SUPPLEMENT
Whey Isolate
Whey HydrolysateDIETARY_SUPPLEMENT
Whey Hydrolysate
Alphalact-AlbuminDIETARY_SUPPLEMENT
Alphalact-Albumin

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI \>30 kg/m2 \& \<45 kg/m2

You may not qualify if:

  • Diabetes
  • lipid lowering drugs
  • Liver-, Kidney- and/or Heart Disease
  • Serious Hypertension (160/110)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Nutrion

Aarhus, 8000, Denmark

Location

MeSH Terms

Conditions

ObesityAtherosclerosis

Interventions

Caseins

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsPhosphoproteins

Study Officials

  • K Hermansen, Professor, MD

    Department of Endocrinology and Metabolism, Aarhus University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 16, 2008

First Posted

December 17, 2008

Study Start

February 1, 2008

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

November 10, 2009

Record last verified: 2009-11

Locations

DK(1)