Whole Milk Compared With Skimmed Milk and Effect on Lipids

March 30, 2018 updated by: Arne Astrup, University of Copenhagen

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 1958
        • Department of Nutrition, Exercise and sports, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
fasting plasma glucose
Time Frame: 3 weeks
3 weeks
fasting serum insulin
Time Frame: 3 weeks
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Tine Tholstrup, Ass Prof., Department of Nutrition, Exercise and Sports, Univeristy of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

February 9, 2017

First Posted (Actual)

February 14, 2017

Study Record Updates

Last Update Posted (Actual)

April 2, 2018

Last Update Submitted That Met QC Criteria

March 30, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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