Text Size

The Effects of Dairy Products on Energy Balance (MEPEB)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
The Danish Dairy Research Foundation, Denmark
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01199835
First received: September 8, 2010
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Obesity
 Other: High Calcium intake from dairy products

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Effects of Dairy Products on Energy Balance

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: 24 weeks ] [ Designated as safety issue: No ]
  • Body weight [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • body composition [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Resting energy expenditure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Appetite regulation [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Lipid profile [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Intestinal micro flora [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • Metabolomics in urine, feces and blood [ Time Frame: 24 week ] [ Designated as safety issue: No ]
  • calcium excretion [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • bone markers [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • vitamin D status [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • calcium status [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
  • lipid metabolism [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01199835

Locations
Denmark
Department of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Ministry of Science, Technology and Innovation, Denmark
The Danish Dairy Research Foundation, Denmark
  More Information

No publications provided

Responsible Party: AAstrup, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01199835     History of Changes
Other Study ID Numbers: B251
Study First Received: September 8, 2010
Last Updated: February 24, 2012
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
obesity
metabolic syndrome
fecal fat excretion
fecal calcium
weight loss
 appetite regulation
intestinal micro flora
lipid profile
energy balance

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
 Signs and Symptoms
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013