ObesityMEPEBNCT01199835
The Effects of Dairy Products on Energy Balance
A study testing High Calcium intake from dairy products in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High Calcium intake from dairy products
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Oct 2012
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- men and women,
- medium overweight (body mass index 28-36 kg/m2),
- 18-60 years old,
- low habitual calcium intake (<800 mg/d)
Who cannot join
- milk allergy, infection diseases and diabetes,
- intake of dietary supplements,
- smoking,
- pregnancy and/or breast feeding,
- any medications known to affect the outcome measurements,
- weigh reducing diet,
- gastrointestinal diseases,
- participation in other intervention studies
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Exercise, Nutrition and Sports, Faculty of Sciences, University of Copenhagen
Frederiksberg, 1958
About this study
The aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.
- Conditions
- Obesity
- Being tested
- High Calcium intake from dairy products
- Keywords
- obesity, metabolic syndrome, fecal fat excretion, fecal calcium, weight loss, appetite regulation, intestinal micro flora, lipid profile, energy balance
- Medical subject headings
- Obesity, Metabolic Syndrome, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Calcium intake from dairy productsOther
High dietary intake of calcium from dairy products (~1200 mg/d)
| Study group | Role | What they receive |
|---|---|---|
| high calcium | Experimental | Dietary intake of calcium ~ 1500 mg/ d, including ~1200 mg/d from dairy products Receives: Other: High Calcium intake from dairy products |
| Low calcium | Active comparator | Low dietary intake of calcium, i.e. ~ <600 mg/d, including 0-1 portion of dairy products Receives: Other: High Calcium intake from dairy products |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal fat excretion
Measured: 24 weeks
Body weight
Measured: 24 weeks
body composition
Measured: 24 weeks
Secondary outcomes (11)
Resting energy expenditure
Measured: 24 weeks
Blood pressure
Measured: 24 weeks
Appetite regulation
Measured: 24 weeks
Lipid profile
Measured: 24 weeks
Intestinal micro flora
Measured: 24 weeks
Metabolomics in urine, feces and blood
Measured: 24 week
calcium excretion
Measured: 24 weeks
bone markers
Measured: 24 weeks
vitamin D status
Measured: 24 weeks
calcium status
Measured: 24 weeks
lipid metabolism
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2012
- Study completionOct 2012
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, The Danish Dairy Research Foundation, Denmark
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01199835
- Sponsor's protocol ID
- B251
- Acronym
- MEPEB
- Status last verified
- Jun 2014
- First submitted
- 8 Sep 2010
- Last updated
- 11 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Dairy Products on Energy Balance
- ClinicalTrials.gov ID
- NCT01199835
- Acronym / sponsor ID
- MEPEB / B251
- Conditions
- Obesity
- Keywords
- obesity, metabolic syndrome, fecal fat excretion, fecal calcium, weight loss, appetite regulation, intestinal micro flora, lipid profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, The Danish Dairy Research Foundation, Denmark
- Study start
- Jun 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Sep 2010 (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 aim of the study is to investigate the long time effects of high and low intake of dairy products on fecal fat excretion, weight loss, blood pressure, lipid profile, lipid oxidation and appetite regulation in moderately overweight men and women over 24 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high calcium | Experimental | Other: High Calcium intake from dairy productsDietary intake of calcium ~ 1500 mg/ d, including ~1200 mg/d from dairy products |
| Low calcium | Active comparator | Other: High Calcium intake from dairy productsLow dietary intake of calcium, i.e. ~ <600 mg/d, including 0-1 portion of dairy products |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- men and women,
- medium overweight (body mass index 28-36 kg/m2),
- 18-60 years old,
- low habitual calcium intake (<800 mg/d)
Key exclusion criteria (8 listed)
- milk allergy, infection diseases and diabetes,
- intake of dietary supplements,
- smoking,
- pregnancy and/or breast feeding,
- any medications known to affect the outcome measurements,
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 |
|---|---|---|
| High Calcium intake from dairy productsHigh dietary intake of calcium from dairy products (~1200 mg/d) | Other | Low calcium, high calcium |
Primary outcome
Fecal fat excretion
Time frame: 24 weeks
Body weight
Time frame: 24 weeks
body composition
Time frame: 24 weeks
11 secondary outcomes
Resting energy expenditure
Time frame: 24 weeks
Blood pressure
Time frame: 24 weeks
Appetite regulation
Time frame: 24 weeks
Lipid profile
Time frame: 24 weeks
Intestinal micro flora
Time frame: 24 weeks
Metabolomics in urine, feces and blood
Time frame: 24 week
calcium excretion
Time frame: 24 weeks
bone markers
Time frame: 24 weeks
vitamin D status
Time frame: 24 weeks
calcium status
Time frame: 24 weeks
lipid metabolism
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Calcium intake from dairy products 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 11 Jun 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fecal fat excretion (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 11 Jun 2014.