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Calcium Intake and Fat Excretion (KIFU/B266)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Arla Foods
The Danish Dairy Research Foundation, Denmark
Information provided by (Responsible Party):
AAstrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01542164
First received: May 26, 2010
Last updated: February 24, 2012
Last verified: February 2012
History of Changes
  Purpose

The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.


Condition
Fat Excretion
Energy Excretion

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Calcium Intake and Fat Excretion - an Observational Study

Resource links provided by NLM:

MedlinePlus related topics: Calcium
U.S. FDA Resources

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • Total fat and energy excretion [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    Total fat and energy excretion in faeces during the test period of 5 consecutive days


Secondary Outcome Measures:
  • p-vitamin D [ Time Frame: 1 day ] [ Designated as safety issue: No ]
  • p-PTH [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Parathyroid hormone (PTH)

  • Selected genetic variations [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    DNA from blood sample

  • Blood lipids and cholesterol [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Total p-cholesterol, p-LDL, p-HDL, p-TG and p-FFA

  • calcium excretion [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    Total calcium excretion in faeces and urin during the test period of 2 consecutive days

  • Gut micro flora [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Identification of gut micro flora

  • NMR-spectroscopy based metabonomics profiling of urin [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    NMR-spectroscopy based metabonomics profiling of each test subject

  • blood pressure [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    Resting blood pressure


Biospecimen Retention:   Samples With DNA

Whole blood, urine and faeces


Estimated Enrollment: 160
Study Start Date: January 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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 for an association between habitual calcium intake and fecal energy and fat excretion, concentrations of substrates involved in energy metabolism, blood pressure and body weight

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Residents of Copenhagen and Sjælland

Criteria

Inclusion Criteria:

  • age between 18 - 50 years
  • healthy
  • weight stable within 4 months prior to the inclusion

Exclusion Criteria:

  • pregnant or lactating
  • uses cholesterol lowering drugs
  • on diet
  • suffering from, now or previously, any gastrointestinal diseases
  • elite athletes
  • participation in other concomitant trial
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01542164

Locations
Denmark
Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg, Copenhagen, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Ministry of Science, Technology and Innovation, Denmark
Arla Foods
The Danish Dairy Research Foundation, Denmark
Investigators
Principal Investigator: Janne K. Lorenzen, Ass`t Prof. Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen
  More Information

No publications provided

Responsible Party: AAstrup, Department of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT01542164     History of Changes
Other Study ID Numbers: H-B-2009-071
Study First Received: May 26, 2010
Last Updated: February 24, 2012
Health Authority: Denmark: National Board of Health

Keywords provided by University of Copenhagen:
Calcium intake
Fat excretion
Energy excretion
Gut micro flora

ClinicalTrials.gov processed this record on May 16, 2013