Whole Milk Compared With Skimmed Milk and Effect on Lipids

University of Copenhagen

Status: Completed

Conditions: Atherosclerosis

Treatments: Other: Milk type

Study type: Interventional

Funder types: Other

Identifiers

NCT03052582

M227

Details and patient eligibility

About

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

Full 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.

Enrollment: 18 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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18 participants in 2 patient groups

Team 1: skimmed/whole

Active Comparator group

Description:

Milktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk

Treatment:

Other: Milk type

Team 2: whole/skimmed

Active Comparator group

Description:

Milktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk

Treatment:

Other: Milk type