Effect of UHT Treated Milk on Blolipid Profile | NCT01753700

Studies
Effect of UHT Treated Milk on Blolipid Profile

NCT01753700

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Dec 20, 2012Estimated

Enrollment

20Estimated

Phase

Not Applicable

Conditions

To Investigate the Effect of UHT Treated Milk Versus Pasteurised Milk on Bloodlipid Profil

Interventions

UHT treated milk

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

Dec 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2012

Primary Completion Date

Mar 2013Estimated

Completion Date

Mar 2013Estimated

First Submitted Date

Dec 17, 2012

First Submission Date that Met QC Criteria

Dec 17, 2012

First Posted Date

Dec 20, 2012Estimated

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

Dec 17, 2012

Last Update Posted Date

Dec 20, 2012Estimated

Name	Class
Arla Foods	INDUSTRY
Hoeng Fonden	UNKNOWN
Bionor Pharma	UNKNOWN

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 studie are to investigate the effect of ultra heat treated (UHT) versus pasteurised milk on bloodlipid profile

Detailed Description

Not provided

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

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
UHT treated milk	Experimental	1,5 L of 1,5% UHT milk pr day for 3 weeks (21days)	Dietary Supplement: UHT treated milk
Paseurised milk	Placebo Comparator	1,5 L 1,5% pasteurised milk pr day for 3 weeks (21 days)	Dietary Supplement: UHT treated milk

Interventions

Name	Type	Description	Arm Group Labels	Other Names
UHT treated milk	Dietary Supplement		Paseurised milk UHT treated milk

Measure	Description	Time Frame
Blood lipids		3 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

healthy men and women
22-50 years of age
BMI 25-30
non smokers

Exclusion Criteria:

lactose intolerance
milk allergy or other types of food allergy
Intestinal, abdominal or endocrinnologic diseases
daily use of dietary supplements incl. vitamins and minerals
cronic diseases (diabetes, CVD etc.)
user of medicin on perscription that can influence the resuts of the study
allergic to paraamino benzoe acid
Physical activity > 10 h pr week
Blood donor
on a diet or change of dietary habits within 3 months
body weigh change > 3 kg within the last 3 month
special diets
concomitant participation on other studies
not able to comply with protocol

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Nutrition, Exercise and Sports	Recruiting	Copenhagen	Frederiksberg	1958	Denmark