NCT00863564

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
12

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Mar 2009

Shorter than P25 for not_applicable obesity

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
16 days until next milestone

First Submitted

Initial submission to the registry

March 17, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 18, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

November 10, 2009

Status Verified

November 1, 2009

Enrollment Period

7 months

First QC Date

March 17, 2009

Last Update Submit

November 9, 2009

Conditions

ObesityPostprandial LipemiaAtherosclerosisInflammationPostprandial Incretins

Keywords

Postprandial PeriodPostprandial LipaemiaIncretinsSubclinical InflammationObesityAtherosclerosisTriglycerideLipoproteinsPostprandial inflammation

Outcome Measures

Primary Outcomes (1)

  • Triglyceride

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

Secondary Outcomes (2)

  • Incretins

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

  • Inflammatory markers

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

Study Arms (4)

Whey Isolate

ACTIVE COMPARATOR
Dietary Supplement: Whey Isolate

Caseine

ACTIVE COMPARATOR
Dietary Supplement: Caseine

Cod

ACTIVE COMPARATOR
Dietary Supplement: Cod

Gluten

ACTIVE COMPARATOR
Dietary Supplement: Gluten

Interventions

CaseineDIETARY_SUPPLEMENT
Caseine
CodDIETARY_SUPPLEMENT
Cod
GlutenDIETARY_SUPPLEMENT
Gluten
Whey IsolateDIETARY_SUPPLEMENT
Whey Isolate

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

Related Publications (1)

  • Holmer-Jensen J, Karhu T, Mortensen LS, Pedersen SB, Herzig KH, Hermansen K. Differential effects of dietary protein sources on postprandial low-grade inflammation after a single high fat meal in obese non-diabetic subjects. Nutr J. 2011 Oct 19;10:115. doi: 10.1186/1475-2891-10-115.

    PMID: 22011432DERIVED

MeSH Terms

Conditions

ObesityAtherosclerosisInflammation

Interventions

CVD protocolGlutens

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

ProlaminsGrain ProteinsPlant ProteinsProteinsAmino Acids, Peptides, and ProteinsSeed Storage Proteins

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
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 17, 2009

First Posted

March 18, 2009

Study Start

March 1, 2009

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

November 10, 2009

Record last verified: 2009-11

Locations

DK(1)