Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg, Copenhagen, 1958, Denmark
Completed
NCT Number: NCT01542164
Calcium Intake and Fat Excretion
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.
Completed
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–50 year
Sex eligibility
All sexes
Study type
Observational
Primary location
About this study
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 for an association between habitual calcium intake and fecal energy and fat excretion, concentrations of substrates involved in energy metabolism, blood pressure and body weight
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- age between 18 - 50 years
- healthy
- weight stable within 4 months prior to the inclusion
Exclusion criteria
- pregnant or lactating
- uses cholesterol lowering drugs
- on diet
- suffering from, now or previously, any gastrointestinal diseases
- elite athletes
- participation in other concomitant trial
Treatment and study plan
Primary outcomes
-
Total fat and energy excretion
Time frame: 5 days
Total fat and energy excretion in faeces during the test period of 5 consecutive days
Secondary outcomes
-
p-vitamin D
Time frame: 1 day
-
p-PTH
Time frame: 1 day
Parathyroid hormone (PTH)
-
Selected genetic variations
Time frame: 1 day
DNA from blood sample
-
Blood lipids and cholesterol
Time frame: 1 day
Total p-cholesterol, p-LDL, p-HDL, p-TG and p-FFA
-
calcium excretion
Time frame: 2 days
Total calcium excretion in faeces and urin during the test period of 2 consecutive days
-
Gut micro flora
Time frame: 1 day
Identification of gut micro flora
-
NMR-spectroscopy based metabonomics profiling of urin
Time frame: 1 day
NMR-spectroscopy based metabonomics profiling of each test subject
-
blood pressure
Time frame: 1 day
Resting blood pressure
Sponsors and collaborators
Lead sponsor
University of Copenhagen
Other
Collaborators
- Arla Foods
- The Danish Dairy Research Foundation, Denmark
- The Ministry of Science, Technology and Innovation, Denmark
Registry information
Official study title
Calcium Intake and Fat Excretion - an Observational Study
Acronym: KIFU/B266
Important dates
- Study start
- 2010
- Primary completion
- 2011
- Study completion
- 2011
- First posted
- Mar 2, 2012
- Registry last updated
- Feb 7, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.