Is There Room for Butter in a Healthy Diet? | NCT02116829

Studies
Is There Room for Butter in a Healthy Diet?

NCT02116829

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Apr 17, 2014Estimated

Enrollment

50Actual

Phase

Not Applicable

Conditions

Atherosclerosis

Interventions

Danish butter
Olive oil

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

Apr 2014

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

Sep 2013

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Apr 15, 2014

First Submission Date that Met QC Criteria

Apr 16, 2014

First Posted Date

Apr 17, 2014Estimated

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

Apr 16, 2014

Last Update Posted Date

Apr 17, 2014Estimated

Name	Class
The Danish Dairy Research Foundation, Denmark	OTHER

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 effects in humans of a moderate butter intake on risk markers of cardiovascular disease compared to a diet with the same amount of olive oil (refined and therefore without polyfenols).

The primary parameters are total cholesterol, LDL- and HDL cholesterol and triglycerides. The secondary parameters are risk markers of diabetes type 2; plasma glucose and insuling as well as the inflammatory marker hs-CRP.

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

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Danish butter, dairy	Experimental		Other: Danish butter
Olive oil, refined	Active Comparator		Other: Olive oil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Danish butter	Other	The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily)	Danish butter, dairy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total cholesterol		5 weeks
LDL cholesterol		5 weeks
HDL cholesterol		5 weeks
Triglycerides		5 weeks

Secondary Outcomes

Measure	Description	Time Frame
Insulin		5 weeks
Glucose		5 weeks
hs-CRP

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sign written consent
Age: 20-70 y
BMI: 18.5 - 32 kg/m2
Healthy men and women (with no known diseases)

Exclusion criteria

Current or previously cardiovascular disease, high blood pressure
Diabetes Mellitus or other severe chronic disease, including severe allergies
Use of dietary supplements and blood donations prior to, and during the study
Known or suspected abuse of alcohol, drugs or medication
Pregnant or are planning pregnancy during the study period
Extreme physical activity level (more than 10 hours tough physical activity pr. week)
Participation in other research studies
Inability, physically or mentally, to comply with the procedures required by the study protocol, as evaluated by the study staff

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tine Tholstrup, PhD	University of Copenhagen	Principal Investigator

Locations

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

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26135349	Derived	Engel S, Tholstrup T. Butter increased total and LDL cholesterol compared with olive oil but resulted in higher HDL cholesterol compared with a habitual diet. Am J Clin Nutr. 2015 Aug;102(2):309-15. doi: 10.3945/ajcn.115.112227. Epub 2015 Jul 1.

ID	Term
D001161	Arteriosclerosis
D001157	Arterial Occlusive Diseases
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

ID	Term
D002079	Butter
D000069463	Olive Oil

ID	Term
D004041	Dietary Fats
D005223	Fats
D008055	Lipids
D003611	Dairy Products
D005502