Dairy Proteins and Postprandial Appetite Regulation and E... | NCT01133964

Studies
Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure

NCT01133964

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Jun 27, 2011Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

Obesity

Interventions

dairy proteins

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

May 27, 2010

First Submission Date that Met QC Criteria

May 28, 2010

First Posted Date

May 31, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 23, 2011

Last Update Posted Date

Jun 27, 2011Estimated

Name	Class
Arla Foods	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Several studies have shown that a high protein intake is associated with a increased loss of body weight and body fat as compared to a diet with a normal or low protein content. The effect seems to be due to a higher diet induced thermogenesis and increase satiety.

Milk has a high content of proteins. It contains two very different types of protein: whey and casein. Whey is a soluble protein whereas casein clots into the stomach, which delays its gastric emptying and thus probably results in a slower release of amino acids. It is therefore very likely that the two types of protein affect the thermogenesis and appetite regulation differently.

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

The study will have a cross-over design including four meals each including a test drink (milk, casein drink, whey drink or water).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
dairy proteins	Dietary 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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Subjective appetite sensation		5 hours
Energy expenditure		5 hours
Substrate oxidation		5 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy males
body mass index (BMI) 25-30 kg/m2
18-50 years
weight stable

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Arne Astrup, Dr.	Department of Human Nutrition, Life, University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department og Human Nutrition, Life, University of Copenhagen		Copenhagen		1958	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided