The Effect of Calcium on Fecal Fat and Energy Excretion

Sponsor

University of Copenhagen (Other)

Overall Status

Unknown status

CT.gov ID

NCT00519909

Collaborator

Arla Foods (Industry), The Danish Dairy Research Foundation, Denmark (Other), FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark (Other), Danish Research Agency (Other)

Enrollment

Location

Arms

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Dairy calcium	N/A

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 if a high calcium intake from dairy products, in diets high or normal in fat content, have an effect on fecal energy and fat excretion, concentrations of substrates involved in energy metabolism and blood pressure.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Study Start Date :

Aug 1, 2007

Anticipated Study Completion Date :

Feb 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Other: 1 Diet with high content of calcium and high content of fat	Other: Dairy calcium Diets with different content of calcium and fat
Other: 2 Diet with low content of calcium and high content of fat	Other: Dairy calcium Diets with different content of calcium and fat
Other: 3 Diet with high content of calcium and normal content of fat	Other: Dairy calcium Diets with different content of calcium and fat
Other: 4 Diet with low content of calcium and normal content of fat	Other: Dairy calcium Diets with different content of calcium and fat
Other: 5 Diet with high content of calcium fra supplement and high content of fat	Other: Dairy calcium Diets with different content of calcium and fat

Outcome Measures

Primary Outcome Measures

Fecal fat excretion, fecal energy excretion, calcium excretion, cholesterol []

Secondary Outcome Measures

Vitamin D, changes in lipolyse []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

healthy meals
BMI 24-31 kg/m2
age between 18-50 years

Exclusion Criteria:

donation of blood 6 months before and under the study
milk allergy, diabetes, hypertension, hyperlipidemia, cronic infectious disease
use of dietary supplements 3 months before and under the study
smoking
elite athletes
use of medication

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen	Frederiksberg		Denmark	1958

Sponsors and Collaborators

University of Copenhagen
Arla Foods
The Danish Dairy Research Foundation, Denmark
FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark
Danish Research Agency

Investigators

Principal Investigator: Janne K Lorenzen, PhD student, Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00519909

Other Study ID Numbers:

H-KF-01-144/02

First Posted:

Aug 23, 2007

Last Update Posted:

Aug 23, 2007

Last Verified:

Aug 1, 2007

Keywords provided by , ,

dairy products, calcium, fat excretion, energy excretion

Additional relevant MeSH terms:

Calcium

Study Results

No Results Posted as of Aug 23, 2007