Whole Milk Compared With Skimmed Milk and Effect on Lipids

Atherosclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03052582
• Other study ID #: M227
• Status: Completed
• Phase: N/A
• First received: February 8, 2017
• Last updated: March 30, 2018
• Start date: October 2015
• Est. completion date: July 2016

Study information

• Verified date: March 2018
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Atherosclerosis

Intervention

Other:
• Milk type

Locations

Country	Name	City	State
Denmark	Department of Nutrition, Exercise and Sports, University of Copenhagen	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting blood lipids	total, LDL and HDL cholesterol and TAG	3 weeks
Secondary	fasting plasma glucose		3 weeks
Secondary	fasting serum insulin		3 weeks