Atherosclerosis Clinical Trial
Official title:
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.
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Nutrition, Exercise and Sports | Copenhagen | Frederiksberg |
Lead Sponsor | Collaborator |
---|---|
University of Copenhagen | The Danish Dairy Research Foundation, Denmark |
Denmark,
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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