Clinical trial NCT03052582: Whole Milk Compared With Skimmed Milk and Effect on Lipids
Official title: Whole Milk Compared With Skimmed Milk and Effect on Lipids - A Randomized, Controlled Cross-over Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2017-02-14
Enrollment: 18
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Fasting blood lipids
timeFrame: 3 weeks
Secondary outcomes:
measure: fasting plasma glucose
timeFrame: 3 weeks
measure: fasting serum insulin
timeFrame: 3 weeks
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Nutrition, Exercise and Sports, University of Copenhagen
Study officials:
affiliation: Department of Nutrition, Exercise and Sports, Univeristy of Copenhagen
name: Tine Tholstrup, Ass Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Engel S, Elhauge M, Tholstrup T. Effect of whole milk compared with skimmed milk on fasting blood lipids in healthy adults: a 3-week randomized crossover study. Eur J Clin Nutr. 2018 Feb;72(2):249-254. doi: 10.1038/s41430-017-0042-5. Epub 2017 Dec 11.