Calcium Intake and Fat Excretion

Completed

• Conditions: Fat Excretion; Energy Excretion

• Registration Number: NCT01542164
• Lead Sponsor: University of Copenhagen

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

Study Timeline

• Study First Submitted: 2010-05-26
• Study Start: 2010-06
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted QC: 2012-02-24
• Study First Posted: 2012-03-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-06
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen; 🇩🇰 Frederiksberg, Copenhagen, Denmark