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Whole Milk Compared With Skimmed Milk and Effect on Lipids

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ClinicalTrials.gov Identifier: NCT03052582
Recruitment Status : Completed
First Posted : February 14, 2017
Last Update Posted : April 2, 2018
Sponsor:
Information provided by (Responsible Party):
Arne Astrup, 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

Condition or disease Intervention/treatment Phase
Atherosclerosis Other: Milk type Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Whole Milk Compared With Skimmed Milk and Effect on Lipids - A Randomized, Controlled Cross-over Study
Actual Study Start Date : October 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Fasting blood lipids [ Time Frame: 3 weeks ]
    total, LDL and HDL cholesterol and TAG


Secondary Outcome Measures :
  1. fasting plasma glucose [ Time Frame: 3 weeks ]
  2. fasting serum insulin [ Time Frame: 3 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03052582


Locations
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Denmark
Department of Nutrition, Exercise and Sports, University of Copenhagen
Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Tine Tholstrup, Ass Prof. Department of Nutrition, Exercise and Sports, Univeristy of Copenhagen
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Arne Astrup, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03052582    
Other Study ID Numbers: M227
First Posted: February 14, 2017    Key Record Dates
Last Update Posted: April 2, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases