High calcium intake in Obesity - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Obesity

Intervention / Treatment

Behavioral: high calcium intake

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 Type

Interventional

Enrollment

18

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Denmark
- - Copenhagen, Denmark, 1958
    - Institute of Human Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: RANDOMIZED
Interventional Model: CROSSOVER
Masking: NONE

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

The Danish Dairy Research Foundation, Denmark

Arla Foods

FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark

Danish Research Agency

Dutch Dairy Organization (NZO)

Pharna Vinci, Denmark

Investigators

Principal Investigator: Arne Astrup, Prof. Dr., Institute of Human Nutrition, the Royal Veterinary & Agricultural University, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Study Completion

October 1, 2005

Study Registration Dates

First Submitted

April 19, 2007

First Submitted That Met QC Criteria