Calcium Intake and Fat Excretion | NCT01542164

Studies
Calcium Intake and Fat Excretion

NCT01542164

Sponsor

University of Copenhagen

Status

Completed

Last Update Posted

Feb 7, 2017Estimated

Enrollment

158Actual

Phase

Not provided

Conditions

Fat Excretion
Energy Excretion

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010Actual

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

May 26, 2010

First Submission Date that Met QC Criteria

Feb 24, 2012

First Posted Date

Mar 2, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 6, 2017

Last Update Posted Date

Feb 7, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Arne Astrup, Department of Human Nutrition, University of CopenhagenPrincipal Investigator

Lead Sponsor

University of CopenhagenOTHER

Collaborators

Name	Class
The Ministry of Science, Technology and Innovation, Denmark	OTHER_GOV
Arla Foods	INDUSTRY
The Danish Dairy Research Foundation, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

158Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Total fat and energy excretion	Total fat and energy excretion in faeces during the test period of 5 consecutive days	5 days

Secondary Outcomes

Measure	Description	Time Frame
p-vitamin D		1 day
p-PTH	Parathyroid hormone (PTH)	1 day
Selected genetic variations

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Residents of Copenhagen and Sjælland

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lesli H. Larsen, Ass. Prof.	Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen		Frederiksberg, Copenhagen		1958	Denmark