Is There Room for Butter in a Healthy Diet?

Atherosclerosis Clinical Trial

Official title:

Is There Room for Butter in a Healthy Diet? - A Randomized Controlled Dietary Human Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02116829
• Other study ID #: A309
• Status: Completed
• Phase: N/A
• First received: April 15, 2014
• Last updated: April 16, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: April 2014
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Other:
• Danish butter
The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily)
• Olive oil

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports	Copenhagen	Frederiksberg

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total cholesterol		5 weeks	No
Primary	LDL cholesterol		5 weeks	No
Primary	HDL cholesterol		5 weeks	No
Primary	Triglycerides		5 weeks	No
Secondary	Insulin		5 weeks	No
Secondary	Glucose		5 weeks	No
Secondary	hs-CRP		5 weeks	No