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

Intervention / Treatment

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

  • Denmark
      • 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
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)

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

University of Copenhagen

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.

General Publications

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

Keywords

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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