Is There Room for Butter in a Healthy Diet?
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 17, 2014
CompletedApril 17, 2014
April 1, 2014
3 months
April 15, 2014
April 16, 2014
Conditions
Outcome Measures
Primary Outcomes (4)
Total cholesterol
5 weeks
LDL cholesterol
5 weeks
HDL cholesterol
5 weeks
Triglycerides
5 weeks
Secondary Outcomes (3)
Insulin
5 weeks
Glucose
5 weeks
hs-CRP
5 weeks
Study Arms (2)
Danish butter, dairy
EXPERIMENTALOlive oil, refined
ACTIVE COMPARATORInterventions
The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily)
Eligibility Criteria
You may qualify if:
- Sign written consent
- Age: 20-70 y
- BMI: 18.5 - 32 kg/m2
- Healthy men and women (with no known diseases)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Nutrition, Exercise and Sports
Copenhagen, Frederiksberg, 1958, Denmark
Related Publications (1)
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.
PMID: 26135349DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tine Tholstrup, PhD
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 15, 2014
First Posted
April 17, 2014
Study Start
September 1, 2013
Primary Completion
December 1, 2013
Study Completion
December 1, 2013
Last Updated
April 17, 2014
Record last verified: 2014-04