- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01317251
Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid (MOFF)
September 4, 2014 updated by: University of Copenhagen
The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids.
To do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males.
Fasting blood samples will be collected before and after each period, and fecal samples will be collected for the last 5 days in each period.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Frederiksberg C, Denmark, 1958
- Department of Human Nutrition, University of Copenhagen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 50 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy males
- BMI 20-28 mg/m2
Exclusion Criteria:
- Smoking
- Medicine use
- Dietary supplements
- Lactose intolerance, milk allergy
- Dislike of dairy products
- Excessive physical activity (> 10h/wk)
- Known chronic illnesses
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Control diet
Diet without dairy products
|
Control diet without dairy products
|
EXPERIMENTAL: Milk diet
Diet with a high content of milk
|
Diet with a high content of milk (~1200 mg Ca/d from milk)
|
EXPERIMENTAL: Cheese diet
Diet with a high content of cheese
|
Diet with a high content of cheese (~1200 mg Ca/d from cheese)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fecal fat excretion
Time Frame: During day 10-14 in each period
|
Total excretion of fecal fat (grams/day)avaraged over five days
|
During day 10-14 in each period
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Total, HDL and LDL cholesterol
Time Frame: Day 1 and 14 in each period
|
Day 1 and 14 in each period
|
Triglycerides
Time Frame: Day 1 and 14 in each period
|
Day 1 and 14 in each period
|
Appetite sensation
Time Frame: Assessed on day 1, 8 and 14 in each period
|
Assessed on day 1, 8 and 14 in each period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Arne Astrup, Dr med, University of Copenhagen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (ACTUAL)
April 1, 2012
Study Completion (ACTUAL)
September 1, 2012
Study Registration Dates
First Submitted
March 11, 2011
First Submitted That Met QC Criteria
March 16, 2011
First Posted (ESTIMATE)
March 17, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
September 5, 2014
Last Update Submitted That Met QC Criteria
September 4, 2014
Last Verified
March 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B281
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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