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The Effect of Calcium on Fecal Fat and Energy Excretion

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2007 by University of Copenhagen.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519909
First Posted: August 23, 2007
Last Update Posted: August 23, 2007
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.
Collaborators:
Arla Foods
The Danish Dairy Research Foundation, Denmark
FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark
Danish Research Agency
Information provided by:
University of Copenhagen
  Purpose
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.

Condition Intervention
Obesity Other: Dairy calcium

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Fecal fat excretion, fecal energy excretion, calcium excretion, cholesterol

Secondary Outcome Measures:
  • Vitamin D, changes in lipolyse

Estimated Enrollment: 15
Study Start Date: August 2007
Estimated Study Completion Date: February 2008
Arms Assigned Interventions
1
Diet with high content of calcium and high content of fat
Other: Dairy calcium
Diets with different content of calcium and fat
2
Diet with low content of calcium and high content of fat
Other: Dairy calcium
Diets with different content of calcium and fat
3
Diet with high content of calcium and normal content of fat
Other: Dairy calcium
Diets with different content of calcium and fat
4
Diet with low content of calcium and normal content of fat
Other: Dairy calcium
Diets with different content of calcium and fat
5
Diet with high content of calcium fra supplement and high content of fat
Other: Dairy calcium
Diets with different content of calcium and fat

Detailed Description:

Several reports have found inverse associations between calcium intake and body weight. Few intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. The mechanism is not clear, but one possible explanation is reduced absorption of fat in the gut, due to formation of insoluble calcium fatty acid soaps or binding of bile acids which impairs the formation of micelles.

The aim of this study is to examined if a high calcium intake from dairy products, in diets high or normal in fat content, have an effect on fecal energy and fat excretion, concentrations of substrates involved in energy metabolism and blood pressure.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • healthy meals
  • BMI 24-31 kg/m2
  • age between 18-50 years

Exclusion Criteria:

  • donation of blood 6 months before and under the study
  • milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease
  • use of dietary supplements 3 months before and under the study
  • smoking
  • elite athletes
  • use of medication
  Contacts and Locations
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): NCT00519909


Contacts
Contact: Arne Astrup, Prof. MD +45 3533 2476 ast@life.ku.dk

Locations
Denmark
Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen Recruiting
Frederiksberg, Denmark, 1958
Contact: Arne Astrup, prof. MD    +45 3533 2476    ast@life.ku.dk   
Contact: Janne K Lorenzen, PhD student    +45 3533 3632    jakh@life.ku.dk   
Principal Investigator: Janne K Lorenzen, PhD student         
Sponsors and Collaborators
University of Copenhagen
Arla Foods
The Danish Dairy Research Foundation, Denmark
FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark
Danish Research Agency
Investigators
Principal Investigator: Janne K Lorenzen, PhD student Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen
  More Information

ClinicalTrials.gov Identifier: NCT00519909     History of Changes
Other Study ID Numbers: H-KF-01-144/02
First Submitted: August 22, 2007
First Posted: August 23, 2007
Last Update Posted: August 23, 2007
Last Verified: August 2007

Keywords provided by University of Copenhagen:
dairy products, calcium, fat excretion, energy excretion

Additional relevant MeSH terms:
Calcium, Dietary
Bone Density Conservation Agents
Physiological Effects of Drugs