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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University of Copenhagen.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01317251
First received: March 11, 2011
Last updated: March 16, 2011
Last verified: March 2011
History of Changes
  Purpose

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 Intervention
Obesity
 Other: Dietary intervention (without dairy products)
Other: Dietary intervention (high milk content)
Other: Dietary intervention (high cheese content)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Fecal fat excretion [ Time Frame: During day 10-14 in each period ] [ Designated as safety issue: No ]
    Total excretion of fecal fat (grams/day)avaraged over five days


Secondary Outcome Measures:
  • Total, HDL and LDL cholesterol [ Time Frame: Day 1 and 14 in each period ] [ Designated as safety issue: No ]
  • Triglycerides [ Time Frame: Day 1 and 14 in each period ] [ Designated as safety issue: No ]
  • Appetite sensation [ Time Frame: Assessed on day 1, 8 and 14 in each period ] [ Designated as safety issue: No ]

Estimated Enrollment: 16
Study Start Date: March 2011
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01317251

Contacts
Contact: Mette Kristensen, PhD +45 35333536 mekr@life.ku.dk

Locations
Denmark
Department of Human Nutrition, University of Copenhagen Recruiting
Frederiksberg C, Denmark, 1958
Sub-Investigator: Mette Kristensen, PhD            
Sponsors and Collaborators
University of Copenhagen
Investigators
Principal Investigator: Arne Astrup, Dr med University of Copenhagen
  More Information

No publications provided

Responsible Party: Mette Kristensen, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01317251     History of Changes
Other Study ID Numbers: B281
Study First Received: March 11, 2011
Last Updated: March 16, 2011
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: Scientific Ethical Committee

Keywords provided by University of Copenhagen:
Obesity prevention
appetite regulation
hyperlipidemia

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013