Calcium Intake and Fat Excretion

Energy Excretion Clinical Trial

— KIFU/B266  

Official title:

Calcium Intake and Fat Excretion - an Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01542164
• Other study ID #: H-B-2009-071
• Status: Completed
• Phase: N/A
• First received: May 26, 2010
• Last updated: February 6, 2017
• Start date: June 2010
• Est. completion date: August 2011

Study information

• Verified date: February 2017
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Energy Excretion
• Fat Excretion

Locations

Country	Name	City	State
Denmark	Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen	Frederiksberg, Copenhagen

Sponsors (4)

Lead Sponsor	Collaborator
University of Copenhagen	Arla Foods, The Danish Dairy Research Foundation, Denmark, The Ministry of Science, Technology and Innovation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total fat and energy excretion	Total fat and energy excretion in faeces during the test period of 5 consecutive days	5 days
Secondary	p-vitamin D		1 day
Secondary	p-PTH	Parathyroid hormone (PTH)	1 day
Secondary	Selected genetic variations	DNA from blood sample	1 day
Secondary	Blood lipids and cholesterol	Total p-cholesterol, p-LDL, p-HDL, p-TG and p-FFA	1 day
Secondary	calcium excretion	Total calcium excretion in faeces and urin during the test period of 2 consecutive days	2 days
Secondary	Gut micro flora	Identification of gut micro flora	1 day
Secondary	NMR-spectroscopy based metabonomics profiling of urin	NMR-spectroscopy based metabonomics profiling of each test subject	1 day
Secondary	blood pressure	Resting blood pressure	1 day