The Effect of Calcium on Fecal Fat and Energy Excretion

Obesity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00519909
• Other study ID #: H-KF-01-144/02
• Status: Recruiting
• Phase: N/A
• First received: August 22, 2007
• Last updated: August 22, 2007
• Start date: August 2007
• Est. completion date: February 2008

Study information

• Verified date: August 2007
• Source: University of Copenhagen
• Contact: Arne Astrup, Prof. MD
• Phone: +45 3533 2476
• Email: ast[@]life.ku.dk
• Is FDA regulated: No
• Health authority: Denmark: Ministry of the Interior and Health
• Study type: Interventional

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: February 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Dairy calcium
Diets with different content of calcium and fat

Locations

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

Sponsors (5)

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

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal fat excretion, fecal energy excretion, calcium excretion, cholesterol
Secondary	Vitamin D, changes in lipolyse