Calcium Intake and Fat Excretion (KIFU/B266)

Calcium Intake and Fat Excretion - an Observational Study

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

Study Overview

• Status: Completed
• Conditions: Fat Excretion; 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 Type: Observational
• Enrollment (Actual): 158

Contacts and Locations

Study Locations

• Denmark
  • Frederiksberg, Copenhagen, Denmark, 1958
    • Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Residents of Copenhagen and Sjælland

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Copenhagen
• Collaborators: The Danish Dairy Research Foundation, Denmark; The Ministry of Science, Technology and Innovation, Denmark; Arla Foods
• Investigators: Principal Investigator: Lesli H. Larsen, Ass. Prof., Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2010
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: May 26, 2010
• First Submitted That Met QC Criteria: February 24, 2012
• First Posted (ESTIMATE): March 2, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 6, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Fat excretion; Calcium intake; Energy excretion; Gut micro flora
• Other Study ID Numbers: H-B-2009-071