Whole Milk Compared With Skimmed Milk and Effect on Lipids

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2016-07-31

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

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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.

Conditions

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Atherosclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Team 1: skimmed/whole

Milktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk

Group Type ACTIVE_COMPARATOR

Milk type

Intervention Type OTHER

Team 2: whole/skimmed

Milktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk

Group Type ACTIVE_COMPARATOR

Milk type

Intervention Type OTHER

Interventions

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Milk type

Intervention Type OTHER

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes