The Effect of Calcium on Fecal Fat and Energy Excretion

August 22, 2007 updated by: University of Copenhagen
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

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, Denmark, 1958
        • Recruiting
        • Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
        • Contact:
          • Arne Astrup, prof. MD
          • Phone Number: +45 3533 2476
          • Email: ast@life.ku.dk
        • Contact:
          • Janne K Lorenzen, PhD student
          • Phone Number: +45 3533 3632
          • Email: jakh@life.ku.dk
        • Principal Investigator:
          • Janne K Lorenzen, PhD student

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

No

Genders Eligible for Study

Male

Description

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

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Diet with high content of calcium and high content of fat
Other: Dairy calcium
Diets with different content of calcium and fat
Other: 2
Diet with low content of calcium and high content of fat
Other: Dairy calcium
Diets with different content of calcium and fat
Other: 3
Diet with high content of calcium and normal content of fat
Other: Dairy calcium
Diets with different content of calcium and fat
Other: 4
Diet with low content of calcium and normal content of fat
Other: Dairy calcium
Diets with different content of calcium and fat
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Fecal fat excretion, fecal energy excretion, calcium excretion, cholesterol

Secondary Outcome Measures

Outcome Measure
Vitamin D, changes in lipolyse

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
Arla Foods
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

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

August 1, 2007

Study Completion (Anticipated)

February 1, 2008

Study Registration Dates

First Submitted

August 22, 2007

First Submitted That Met QC Criteria

August 22, 2007

First Posted (Estimate)

August 23, 2007

Study Record Updates

Last Update Posted (Estimate)

August 23, 2007

Last Update Submitted That Met QC Criteria

August 22, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-KF-01-144/02

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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