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Completed

NCT Number: NCT02116829

Is There Room for Butter in a Healthy Diet?

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.

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Key information

Conditions

Atherosclerosis Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Vascular Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports

Copenhagen, Frederiksberg, 1958, Denmark

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danish butter

Other

The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily)

Other names: butter, diary

olive oil

Other

Primary outcomes

  1. Total cholesterol

    Time frame: 5 weeks

  2. LDL cholesterol

    Time frame: 5 weeks

  3. HDL cholesterol

    Time frame: 5 weeks

  4. Triglycerides

    Time frame: 5 weeks

Secondary outcomes

  1. Insulin

    Time frame: 5 weeks

  2. Glucose

    Time frame: 5 weeks

  3. hs-CRP

    Time frame: 5 weeks

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • The Danish Dairy Research Foundation, Denmark

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Apr 17, 2014
Registry last updated
Apr 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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