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Whole Milk Compared With Skimmed Milk and Effect on Lipids

Primary Purpose

Atherosclerosis

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Milk type

About this trial

This is an interventional prevention trial for Atherosclerosis

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Department of Nutrition, Exercise and Sports, University of Copenhagen

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Team 1: skimmed/whole

Team 2: whole/skimmed

Arm Description

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

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

Outcomes

Primary Outcome Measures

Fasting blood lipids

total, LDL and HDL cholesterol and TAG

Secondary Outcome Measures

fasting plasma glucose

fasting serum insulin

Full Information

NCT ID

NCT03052582

First Posted

February 8, 2017

Last Updated

March 30, 2018

Sponsor

University of Copenhagen

1. Study Identification

Unique Protocol Identification Number

NCT03052582

Brief Title

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

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

October 2015 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Copenhagen

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atherosclerosis

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

18 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Team 1: skimmed/whole

Arm Type

Active Comparator

Arm Description

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

Arm Title

Team 2: whole/skimmed

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Milk type

Primary Outcome Measure Information:

Title

Fasting blood lipids

Description

total, LDL and HDL cholesterol and TAG

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

fasting plasma glucose

Time Frame

3 weeks

Title

fasting serum insulin

Time Frame

3 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tine Tholstrup, Ass Prof.

Organizational Affiliation

Department of Nutrition, Exercise and Sports, Univeristy of Copenhagen

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Nutrition, Exercise and Sports, University of Copenhagen

City

Copenhagen

ZIP/Postal Code

1958

Country

Denmark

12. IPD Sharing Statement

Citations:

PubMed Identifier

29229955

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.

Results Reference

derived

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Whole Milk Compared With Skimmed Milk and Effect on Lipids

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