Is There Room for Butter in a Healthy Diet?

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

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.

Study Overview

• Status: Completed
• Conditions: Atherosclerosis
• Intervention / Treatment: Other: Danish butter; Other: Olive oil

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg
    • Copenhagen, Frederiksberg, Denmark, 1958
      • Department of Nutrition, Exercise and Sports

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 66 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Danish butter, dairy	Other: Danish butter; The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily); Other Names: butter, diary
Active Comparator: Olive oil, refined	Other: Olive oil

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: The Danish Dairy Research Foundation, Denmark
• Investigators: Principal Investigator: Tine Tholstrup, PhD, Department of Nutrition, Exercise and sports, University of Copenhagen

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: April 15, 2014
• First Submitted That Met QC Criteria: April 16, 2014
• First Posted (Estimate): April 17, 2014

Study Record Updates

• Last Update Posted (Estimate): April 17, 2014
• Last Update Submitted That Met QC Criteria: April 16, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis
• Other Study ID Numbers: A309