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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00464035
Other study ID # KF 01-144/02
Secondary ID
Status Completed
Phase N/A
First received April 19, 2007
Last updated January 20, 2009
Start date February 2005
Est. completion date October 2005

Study information

Verified date December 2004
Source University of Copenhagen
Contact n/a
Is FDA regulated No
Health authority Denmark: Ministry of the Interior and Health
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date October 2005
Est. primary completion date
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

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Behavioral:
high calcium intake


Locations

Country Name City State
Denmark Institute of Human Nutrition Copenhagen

Sponsors (7)

Lead Sponsor Collaborator
University of Copenhagen Arla Foods, Danish Research Agency, Dutch Dairy Organization (NZO), FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark, Pharna Vinci, Denmark, The Danish Dairy Research Foundation, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Postprandial changes in: total plasma triacylglyceride; Chylomicron triacylglyceride; Cholesterol
Secondary Postprandial changes in:insulin; glucose; CCK; Ghrelin; GLP-1, appetite measured by visual analogue scales, BCAA
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