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Calcium Intake and Fat Excretion (KIFU/B266)

This study has been completed.
Sponsor:
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Arla Foods
The Danish Dairy Research Foundation, Denmark
Information provided by (Responsible Party):
Arne Astrup, University of Copenhagen
ClinicalTrials.gov Identifier:
NCT01542164
First received: May 26, 2010
Last updated: February 6, 2017
Last verified: February 2017
  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: Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Calcium Intake and Fat Excretion - an Observational Study

Resource links provided by NLM:


Further study details as provided by Arne Astrup, University of Copenhagen:

Primary Outcome Measures:
  • Total fat and energy excretion [ Time Frame: 5 days ]
    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 ]
  • p-PTH [ Time Frame: 1 day ]
    Parathyroid hormone (PTH)

  • Selected genetic variations [ Time Frame: 1 day ]
    DNA from blood sample

  • Blood lipids and cholesterol [ Time Frame: 1 day ]
    Total p-cholesterol, p-LDL, p-HDL, p-TG and p-FFA

  • calcium excretion [ Time Frame: 2 days ]
    Total calcium excretion in faeces and urin during the test period of 2 consecutive days

  • Gut micro flora [ Time Frame: 1 day ]
    Identification of gut micro flora

  • NMR-spectroscopy based metabonomics profiling of urin [ Time Frame: 1 day ]
    NMR-spectroscopy based metabonomics profiling of each test subject

  • blood pressure [ Time Frame: 1 day ]
    Resting blood pressure


Biospecimen Retention:   Samples With DNA
Whole blood, urine and faeces

Enrollment: 158
Actual Study Start Date: June 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (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   (Adult)
Sexes Eligible for Study:   All
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
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, see Learn About Clinical Studies.

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: Lesli H. Larsen, Ass. Prof. Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen
  More Information

Responsible Party: Arne Astrup, 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 6, 2017

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

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

ClinicalTrials.gov processed this record on June 23, 2017