Whole Milk Compared With Skimmed Milk and Effect on Lipids

Study Overview
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Brief Summary
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The aim of the project is to investigate the effects in humans of a daily intake of whole milk compared to skimmed milk primarily and secondarily respectively on: Blood lipids: total-, LDL-, and HDL-cholesterol and triglycerides Risk markers of diabetes type 2: plasma glucose and insulin

Detailed Description
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This study will be a randomized controlled 2 x 3 weeks crossover intervention study with no wash-out period, as the lipids in the blood are known to adjust after 2 weeks. The effects of a diet containing 0.5 L of whole milk (17.5 g of milk fat/day) will be compared with a diet containing 0.5 L of skimmed milk (1.5 g of milk fat/day). Blinding is not possible since the appearance of the test foods cannot be concealed. The study subjects will receive the two test foods in random order, decided by draw of lots. Blood samples will be drawn on the first day of the period and in the end of the period for each 3 week-periods.

Official Title
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Whole Milk Compared With Skimmed Milk and Effect on Lipids - A Randomized, Controlled Cross-over Study

Conditions
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Atherosclerosis

Intervention / Treatment
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* Other: Milk type


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All subjects must give their informed consent in writing, after having received oral and written information about the study Age: 20-70 y BMI: 18.5 - 30 kg/m2 Healthy men and women (with no known diseases) Exclusion Criteria: Current or previous cardiovascular disease, high blood pressure or cholesterol Diabetes Mellitus or other severe chronic disease, including severe allergies Lactose intolerant or milk allergy Use of dietary supplements two month prior to and during the intervention Blood donations 1 month prior to and during the intervention 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Team 1: skimmed/whole<br>Milktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk | Other: Milk type<br> <br> |
| Active Comparator: Team 2: whole/skimmed<br>Milktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk | Other: Milk type<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting blood lipids | total, LDL and HDL cholesterol and TAG | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting plasma glucose |  | 3 weeks | 
| fasting serum insulin |  | 3 weeks |