ObesityNCT00519909
The Effect of Calcium on Fecal Fat and Energy Excretion
A study testing Dairy calcium in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Dairy calcium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2007to Feb 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy meals
- BMI 24-31 kg/m2
- age between 18-50 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg, 1958
Arne Astrup, prof. MD, +45 3533 2476, ast@life.ku.dk
Janne K Lorenzen, PhD student, +45 3533 3632, jakh@life.ku.dk
About this study
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.
Read the detailed description
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 if a high calcium intake from dairy products, in diets high or normal in fat content, have an effect on fecal energy and fat excretion, concentrations of substrates involved in energy metabolism and blood pressure.
- Conditions
- Obesity
- Being tested
- Dairy calcium
- Keywords
- dairy products, calcium, fat excretion, energy excretion
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dairy calciumOther
Diets with different content of calcium and fat
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | Diet with high content of calcium and high content of fat Receives: Other: Dairy calcium |
| 2 | Other | Diet with low content of calcium and high content of fat Receives: Other: Dairy calcium |
| 3 | Other | Diet with high content of calcium and normal content of fat Receives: Other: Dairy calcium |
| 4 | Other | Diet with low content of calcium and normal content of fat Receives: Other: Dairy calcium |
| 5 | Other | Diet with high content of calcium fra supplement and high content of fat Receives: Other: Dairy calcium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal fat excretion, fecal energy excretion, calcium excretion, cholesterol
Secondary outcomes (1)
Vitamin D, changes in lipolyse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startAug 2007
- Study completionFeb 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods, The Danish Dairy Research Foundation, Denmark, FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark, Danish Research Agency
- Investigators
- Janne K Lorenzen, PhD student, Principal investigator, Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519909
- Sponsor's protocol ID
- H-KF-01-144/02
- Status last verified
- Aug 2007
- First submitted
- 22 Aug 2007
- Last updated
- 23 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Calcium on Fecal Fat and Energy Excretion
- ClinicalTrials.gov ID
- NCT00519909
- Acronym / sponsor ID
- H-KF-01-144/02
- Conditions
- Obesity
- Keywords
- dairy products, calcium, fat excretion, energy excretion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Arla Foods, The Danish Dairy Research Foundation, Denmark, FOOD Graduate School, the Royal Veterinary & Agricultural University, Denmark, Danish Research Agency
- Study start
- Aug 2007
- Study completion
- Feb 2008 (estimated)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.
Detailed description
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 if a high calcium intake from dairy products, in diets high or normal in fat content, have an effect on fecal energy and fat excretion, concentrations of substrates involved in energy metabolism and blood pressure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Other: Dairy calciumDiet with high content of calcium and high content of fat |
| 2 | Other | Other: Dairy calciumDiet with low content of calcium and high content of fat |
| 3 | Other | Other: Dairy calciumDiet with high content of calcium and normal content of fat |
| 4 | Other | Other: Dairy calciumDiet with low content of calcium and normal content of fat |
| 5 | Other | Other: Dairy calciumDiet with high content of calcium fra supplement and high content of fat |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- healthy meals
- BMI 24-31 kg/m2
- age between 18-50 years
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dairy calciumDiets with different content of calcium and fat | Other | 1, 2, 3, 4, 5 |
Primary outcome
Fecal fat excretion, fecal energy excretion, calcium excretion, cholesterol
1 secondary outcome
Vitamin D, changes in lipolyse
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2007.
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janne K Lorenzen, PhD student principal investigator
Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dairy calcium in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arne Astrup, Prof. MD (+45 3533 2476, ast@life.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal fat excretion, fecal energy excretion, calcium excretion, cholesterol. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2007.