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Is There Room for Butter in a Healthy Diet?

Primary Purpose

Atherosclerosis

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Danish butter
Olive oil
Sponsored by
University of Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Atherosclerosis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Department of Nutrition, Exercise and Sports

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Danish butter, dairy

Olive oil, refined

Arm Description

Outcomes

Primary Outcome Measures

Total cholesterol
LDL cholesterol
HDL cholesterol
Triglycerides

Secondary Outcome Measures

Insulin
Glucose
hs-CRP

Full Information

First Posted
April 15, 2014
Last Updated
April 16, 2014
Sponsor
University of Copenhagen
Collaborators
The Danish Dairy Research Foundation, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02116829
Brief Title
Is There Room for Butter in a Healthy Diet?
Official Title
Is There Room for Butter in a Healthy Diet? - A Randomized Controlled Dietary Human Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
The Danish Dairy Research Foundation, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atherosclerosis

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Danish butter, dairy
Arm Type
Experimental
Arm Title
Olive oil, refined
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Danish butter
Other Intervention Name(s)
butter, diary
Intervention Description
The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily)
Intervention Type
Other
Intervention Name(s)
Olive oil
Primary Outcome Measure Information:
Title
Total cholesterol
Time Frame
5 weeks
Title
LDL cholesterol
Time Frame
5 weeks
Title
HDL cholesterol
Time Frame
5 weeks
Title
Triglycerides
Time Frame
5 weeks
Secondary Outcome Measure Information:
Title
Insulin
Time Frame
5 weeks
Title
Glucose
Time Frame
5 weeks
Title
hs-CRP
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tine Tholstrup, PhD
Organizational Affiliation
Department of Nutrition, Exercise and sports, University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Nutrition, Exercise and Sports
City
Copenhagen
State/Province
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark

12. IPD Sharing Statement

Citations:
PubMed Identifier
26135349
Citation
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.
Results Reference
derived

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Is There Room for Butter in a Healthy Diet?

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