The Effect of Calcium on Postprandial Lipid Profile and Appetite - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 19, 2007

Last Updated Date

January 20, 2009

Start Date ^†

February 2005

Current Primary Outcome Measures ^†

Postprandial changes in: total plasma triacylglyceride; Chylomicron triacylglyceride; Cholesterol

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00464035 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Postprandial changes in:insulin; glucose; CCK; Ghrelin; GLP-1, appetite measured by visual analogue scales, BCAA

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

The Effect of Calcium on Postprandial Lipid Profile and Appetite

Official Title ^†

Brief Summary

The purpose of this study is to investigate the effect of calcium on postprandial lipid profile and appetite.

Detailed Description

Several reports have found inverse associations between calcium intake and body weight. Intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. In addition, it seems that calcium from dairy products have a more profound effect than calcium from supplements. The mechanism of this additional dairy effect is not yet clear, but one possible explanation could be reduced absorption of fat in the gut. The increase in fecal fat excretion on a high calcium diet could be due to the formation of calcium-fatty acid soaps in the gut.

The long term effect of a high calcium intake have been under intense investigation, but as far as we know the acute effect of a high calcium intake have not yet been examined. A study concerning the acute effects could help us understand the effect of calcium on the absorption of fat. After a meal triglyceride (TG) is packaged with cholesterol, lipoproteins and other lipids into particles called chylomicrons. Earlier studies have shown that the fatty acid pattern of chylomicron lipids postprandial was very similar to that of the ingested fat. If we assume that calcium inhibits the absorption of fat, we would expect a reduced total plasma triglyceride concentration after a calcium-rich meal.

Appetite involves many different sensations among which hunger and satiety are the most investigated. Several different hormones are involved in the regulation of appetite. Some of these hormones are known to respond to the intake or absorption of fat. If the absorption of fat is inhibited the regulation of appetite most likely will be affected. In the long term this could be important because an increased appetite probably would increase energy intake and thereby reducing the weight loss we otherwise might have accomplished by the reduced absorption of fat.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Other, Randomized, Open Label, Placebo Control, Crossover Assignment, Efficacy Study

Condition ^†

Obesity

Intervention ^†

Behavioral: high calcium intake

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Completed

Enrollment ^†

Completion Date

October 2005

Primary Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

healthy meals
BMI 24-31 kg/m2
age between 18-50 years
hemoglobin >8 mmol/L

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

Gender

Male

Ages

18 Years to 50 Years

Accepts Healthy Volunteers

Yes

Contacts ^††

Location Countries ^†

Denmark

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00464035

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

University of Copenhagen

Collaborators ^††

Arla amba, Denmark
The Danish Dairy Research Foundation, Denmark
FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark
The Danish Research Agency, Denmark
Dutch dairy Association, Holland
Pharna Vinci, Denmark

Investigators ^†

Principal Investigator:

Arne Astrup, Prof. Dr.

Institute of Human Nutrition, the Royal Veterinary & Agricultural University, Denmark

Information Provided By

University of Copenhagen

Verification Date

December 2004

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.