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Whole Milk Compared With Skimmed Milk and Effect on Lipids

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03052582
Enrollment
18
Registered
2017-02-14
Start date
2015-10-31
Completion date
2016-07-31
Last updated
2018-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atherosclerosis

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.

Interventions

OTHERMilk type

Sponsors

University of Copenhagen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Fasting blood lipids3 weekstotal, LDL and HDL cholesterol and TAG

Secondary

MeasureTime frame
fasting plasma glucose3 weeks
fasting serum insulin3 weeks

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026