Whole Milk Compared With Skimmed Milk and Effect on Lipids

Not Applicable

Completed

• Conditions: Atherosclerosis
• Interventions: Other: Milk type

• Registration Number: NCT03052582
• Lead Sponsor: University of Copenhagen

Brief Summary

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

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.

Study Timeline

• Study Start: 2015-10
• Primary Completion: 2015-12
• Study Completion: 2016-07
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-02-09
• Study First Posted: 2017-02-14
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-30
• Last Update Posted: 2018-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Team 2: whole/skimmed	Milk type	Milktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk
Team 1: skimmed/whole	Milk type	Milktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk

Primary Outcome Measures

Name	Time	Method
Fasting blood lipids	3 weeks	total, LDL and HDL cholesterol and TAG

Secondary Outcome Measures

Name	Time	Method
fasting plasma glucose	3 weeks
fasting serum insulin	3 weeks

Trial Locations

Locations (1)

Department of Nutrition, Exercise and Sports, University of Copenhagen; 🇩🇰 Copenhagen, Denmark