NCT00519909

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Aug 2007

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 23, 2007

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

August 23, 2007

Status Verified

August 1, 2007

First QC Date

August 22, 2007

Last Update Submit

August 22, 2007

Conditions

Obesity

Keywords

dairy products, calcium, fat excretion, energy excretion

Outcome Measures

Primary Outcomes (1)

  • Fecal fat excretion, fecal energy excretion, calcium excretion, cholesterol

Secondary Outcomes (1)

  • Vitamin D, changes in lipolyse

Study Arms (5)

1

OTHER

Diet with high content of calcium and high content of fat

Other: Dairy calcium

2

OTHER

Diet with low content of calcium and high content of fat

Other: Dairy calcium

3

OTHER

Diet with high content of calcium and normal content of fat

Other: Dairy calcium

4

OTHER

Diet with low content of calcium and normal content of fat

Other: Dairy calcium

5

OTHER

Diet with high content of calcium fra supplement and high content of fat

Other: Dairy calcium

Interventions

Dairy calciumOTHER

Diets with different content of calcium and fat

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Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen

Frederiksberg, 1958, Denmark

RECRUITING

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Janne K Lorenzen, PhD student

    Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arne Astrup, Prof. MD

CONTACT

+45 3533 2476ast@life.ku.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 22, 2007

First Posted

August 23, 2007

Study Start

August 1, 2007

Study Completion

February 1, 2008

Last Updated

August 23, 2007

Record last verified: 2007-08

Locations

DK(1)