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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02116829
Other study ID # A309
Secondary ID
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


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
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