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Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid (MOFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01317251
Recruitment Status : Completed
First Posted : March 17, 2011
Last Update Posted : September 5, 2014
Sponsor:
Information provided by:
University of Copenhagen

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Obesity Other: Dietary intervention (without dairy products) Other: Dietary intervention (high milk content) Other: Dietary intervention (high cheese content) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid
Study Start Date : March 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arms and Interventions
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Arm Intervention/treatment
Experimental: Control diet
Diet without dairy products
 Other: Dietary intervention (without dairy products)
Control diet without dairy products
Experimental: Milk diet
Diet with a high content of milk
 Other: Dietary intervention (high milk content)
Diet with a high content of milk (~1200 mg Ca/d from milk)
Experimental: Cheese diet
Diet with a high content of cheese
 Other: Dietary intervention (high cheese content)
Diet with a high content of cheese (~1200 mg Ca/d from cheese)


Outcome Measures
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Primary Outcome Measures :
  1. Fecal fat excretion [ Time Frame: During day 10-14 in each period ]
    Total excretion of fecal fat (grams/day)avaraged over five days


Secondary Outcome Measures :
  1. Total, HDL and LDL cholesterol [ Time Frame: Day 1 and 14 in each period ]
  2. Triglycerides [ Time Frame: Day 1 and 14 in each period ]
  3. Appetite sensation [ Time Frame: Assessed on day 1, 8 and 14 in each period ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01317251


Locations
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Denmark
Department of Human Nutrition, University of Copenhagen
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Investigators
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Principal Investigator: Arne Astrup, Dr med University of Copenhagen
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mette Kristensen, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01317251    
Other Study ID Numbers: B281
First Posted: March 17, 2011    Key Record Dates
Last Update Posted: September 5, 2014
Last Verified: March 2011
Keywords provided by University of Copenhagen:
Obesity prevention
appetite regulation
hyperlipidemia
Additional relevant MeSH terms:
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Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight