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Completed

NCT Number: NCT03052582

Whole Milk Compared With Skimmed Milk and Effect on Lipids

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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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Nutrition, Exercise and Sports, University of Copenhagen

Copenhagen, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Milk type

Other

Primary outcomes

  1. Fasting blood lipids

    Time frame: 3 weeks

    total, LDL and HDL cholesterol and TAG

Secondary outcomes

  1. fasting plasma glucose

    Time frame: 3 weeks

  2. fasting serum insulin

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2016
First posted
Feb 14, 2017
Registry last updated
Apr 2, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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