NCT01133964

Brief Summary

The aim of this study is to examine the effect of dairy proteins (whey and casein) on postprandial appetite regulation and energy expenditure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Oct 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 31, 2010

Completed
Last Updated

June 27, 2011

Status Verified

September 1, 2008

Enrollment Period

1.2 years

First QC Date

May 27, 2010

Last Update Submit

June 23, 2011

Conditions

Obesity

Keywords

Dairy proteinsAppetite regulationEnergy expenditure

Outcome Measures

Primary Outcomes (3)

  • Subjective appetite sensation

    5 hours

  • Energy expenditure

    5 hours

  • Substrate oxidation

    5 hours

Study Arms (4)

milk

EXPERIMENTAL

skim milk

Dietary Supplement: dairy proteins

casein drink

EXPERIMENTAL
Dietary Supplement: dairy proteins

whey drink

EXPERIMENTAL
Dietary Supplement: dairy proteins

water

SHAM COMPARATOR
Dietary Supplement: dairy proteins

Interventions

dairy proteinsDIETARY_SUPPLEMENT

Protein drinks with 3.5% protein. The protein source will be whey, casein or whey and casein (20:80; normal content in the milk). In the arm with water no protein will be added.

casein drinkmilkwaterwhey drink

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy males
  • body mass index (BMI) 25-30 kg/m2
  • years
  • weight stable

You may not qualify if:

  • smoker
  • regular use of medicine
  • elitist athletes
  • participation in other intervention studies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department og Human Nutrition, Life, University of Copenhagen

Copenhagen, 1958, Denmark

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Arne Astrup, Dr.

    Department of Human Nutrition, Life, University of Copenhagen

    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

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 31, 2010

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

June 27, 2011

Record last verified: 2008-09

Locations

DK(1)