Whole Milk Compared With Skimmed Milk and Effect on Lipids - A Randomized, Controlled Cross-over Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Copenhagen
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Fasting blood lipids
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Team 1: skimmed/whole
Milktype: 3 weeks with skimmed milk followed by 3 weeks with whole milk
Intervention: Milk type (Other)
Team 2: whole/skimmed
Milktype: 3 weeks with whole milk followed by 3 weeks with skimmed milk
Intervention: Milk type (Other)
Outcomes
Primary Outcomes
Fasting blood lipids
Time Frame: 3 weeks
total, LDL and HDL cholesterol and TAG
Secondary Outcomes
- fasting plasma glucose(3 weeks)
- fasting serum insulin(3 weeks)
Investigators
Arne Astrup
Professor
University of Copenhagen