The Effects of Dairy Products on Energy Balance (MEPEB)

June 10, 2014 updated by: Arne Astrup, University of Copenhagen
The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

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, Denmark, 1958
        • Department of Exercise, Nutrition and Sports, Faculty of Sciences, 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 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • men and women,
  • medium overweight (body mass index 28-36 kg/m2),
  • 18-60 years old,
  • low habitual calcium intake (<800 mg/d)

Exclusion Criteria:

  • milk allergy, infection diseases and diabetes,
  • intake of dietary supplements,
  • smoking,
  • pregnancy and/or breast feeding,
  • any medications known to affect the outcome measurements,
  • weigh reducing diet,
  • gastrointestinal diseases,
  • participation in other intervention studies

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: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: high calcium
Dietary intake of calcium ~ 1500 mg/ d, including ~1200 mg/d from dairy products
Other: High Calcium intake from dairy products
High dietary intake of calcium from dairy products (~1200 mg/d)
Active Comparator: Low calcium
Low dietary intake of calcium, i.e. ~ <600 mg/d, including 0-1 portion of dairy products
Other: High Calcium intake from dairy products
High dietary intake of calcium from dairy products (~1200 mg/d)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body weight
Time Frame: 24 weeks
24 weeks
Fecal fat excretion
Time Frame: 24 weeks
24 weeks
body composition
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: 24 weeks
24 weeks
Lipid profile
Time Frame: 24 weeks
24 weeks
Resting energy expenditure
Time Frame: 24 weeks
24 weeks
Appetite regulation
Time Frame: 24 weeks
24 weeks
Intestinal micro flora
Time Frame: 24 weeks
24 weeks
Metabolomics in urine, feces and blood
Time Frame: 24 week
24 week
calcium excretion
Time Frame: 24 weeks
24 weeks
bone markers
Time Frame: 24 weeks
24 weeks
vitamin D status
Time Frame: 24 weeks
24 weeks
calcium status
Time Frame: 24 weeks
24 weeks
lipid metabolism
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

The Danish Dairy Research Foundation, Denmark
The Ministry of Science, Technology and Innovation, Denmark

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

June 1, 2010

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

September 8, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Estimate)

June 11, 2014

Last Update Submitted That Met QC Criteria

June 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B251

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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