NCT01542164

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
158

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2010

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
7 months until next milestone

First Posted

Study publicly available on registry

March 2, 2012

Completed
Last Updated

February 7, 2017

Status Verified

February 1, 2017

Enrollment Period

1.2 years

First QC Date

May 26, 2010

Last Update Submit

February 6, 2017

Conditions

Fat ExcretionEnergy Excretion

Keywords

Calcium intakeFat excretionEnergy excretionGut micro flora

Outcome Measures

Primary Outcomes (1)

  • Total fat and energy excretion

    Total fat and energy excretion in faeces during the test period of 5 consecutive days

    5 days

Secondary Outcomes (8)

  • p-vitamin D

    1 day

  • p-PTH

    1 day

  • Selected genetic variations

    1 day

  • Blood lipids and cholesterol

    1 day

  • calcium excretion

    2 days

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Residents of Copenhagen and Sjælland

You may qualify if:

  • age between 18 - 50 years
  • healthy

You may not qualify if:

  • pregnant or lactating
  • uses cholesterol lowering drugs
  • on diet
  • suffering from, now or previously, any gastrointestinal diseases
  • elite athletes
  • participation in other concomitant trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Frederiksberg, Copenhagen, 1958, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, urine and faeces

Study Officials

  • Lesli H. Larsen, Ass. Prof.

    Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Department of Human Nutrition

Study Record Dates

First Submitted

May 26, 2010

First Posted

March 2, 2012

Study Start

June 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

February 7, 2017

Record last verified: 2017-02

Locations

DK(1)