ObesityMOFFNCT01317251
Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid
A study testing Dietary intervention (without dairy products), Dietary intervention (high milk content) and Dietary intervention (high cheese content) in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids. To do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males. 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?
- Dietary intervention (without dairy products), Dietary intervention (high milk content) and Dietary intervention (high cheese content)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2011to Sep 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 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males
- BMI 20-28 mg/m2
Who cannot join
- Smoking
- Medicine use
- Dietary supplements
- Lactose intolerance, milk allergy
- Dislike of dairy products
- Excessive physical activity (> 10h/wk)
- Known chronic illnesses
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Human Nutrition, University of Copenhagen
Frederiksberg C, 1958
About this study
The aim is to study the effect of milk versus cheese on fecal fat excretion and blood lipids. To do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be collected before and after each period, and fecal samples will be collected for the last 5 days in each period.
- Conditions
- Obesity
- Being tested
- Dietary intervention (without dairy products), Dietary intervention (high milk content), Dietary intervention (high cheese content)
- Keywords
- Obesity prevention, appetite regulation, hyperlipidemia
- Medical subject headings
- Obesity, Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary intervention (without dairy products)Other
Control diet without dairy products
Dietary intervention (high milk content)Other
Diet with a high content of milk (~1200 mg Ca/d from milk)
Dietary intervention (high cheese content)Other
Diet with a high content of cheese (~1200 mg Ca/d from cheese)
| Study group | Role | What they receive |
|---|---|---|
| Control diet | Experimental | Diet without dairy products Receives: Other: Dietary intervention (without dairy products) |
| Milk diet | Experimental | Diet with a high content of milk Receives: Other: Dietary intervention (high milk content) |
| Cheese diet | Experimental | Diet with a high content of cheese Receives: Other: Dietary intervention (high cheese content) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fecal fat excretion
Total excretion of fecal fat (grams/day)avaraged over five days
Measured: During day 10-14 in each period
Secondary outcomes (3)
Total, HDL and LDL cholesterol
Measured: Day 1 and 14 in each period
Triglycerides
Measured: Day 1 and 14 in each period
Appetite sensation
Measured: Assessed on day 1, 8 and 14 in each period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Investigators
- Arne Astrup, Dr med, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01317251
- Sponsor's protocol ID
- B281
- Acronym
- MOFF
- Status last verified
- Mar 2011
- First submitted
- 11 Mar 2011
- Last updated
- 5 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Soerensen KV, Thorning TK, Astrup A, Kristensen M, Lorenzen JK. Effect of dairy calcium from cheese and milk on fecal fat excretion, blood lipids, and appetite in young men. Am J Clin Nutr. 2014 May;99(5):984-91. doi: 10.3945/ajcn.113.077735. Epub 2014 Mar 12.
PubMed 24622806
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Milk and Cheese on Fecal Fat Excretion and Blood Lipid
- ClinicalTrials.gov ID
- NCT01317251
- Acronym / sponsor ID
- MOFF / B281
- Conditions
- Obesity
- Keywords
- Obesity prevention, appetite regulation, hyperlipidemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 17 Mar 2011 (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 is to study the effect of milk versus cheese on fecal fat excretion and blood lipids. To do this, a randomized crossover intervention study with 3 14-day periods (control diet, milk diet, cheese diet) will be conducted in 16 young males. Fasting blood samples will be collected before and after each period, and fecal samples will be collected for the last 5 days in each period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control diet | Experimental | Other: Dietary intervention (without dairy products)Diet without dairy products |
| Milk diet | Experimental | Other: Dietary intervention (high milk content)Diet with a high content of milk |
| Cheese diet | Experimental | Other: Dietary intervention (high cheese content)Diet with a high content of cheese |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy males
- BMI 20-28 mg/m2
Key exclusion criteria (7 listed)
- Smoking
- Medicine use
- Dietary supplements
- Lactose intolerance, milk allergy
- Dislike of dairy products
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 |
|---|---|---|
| Dietary intervention (without dairy products)Control diet without dairy products | Other | Control diet |
| Dietary intervention (high milk content)Diet with a high content of milk (~1200 mg Ca/d from milk) | Other | Milk diet |
| Dietary intervention (high cheese content)Diet with a high content of cheese (~1200 mg Ca/d from cheese) | Other | Cheese diet |
Primary outcome
Fecal fat excretion
Time frame: During day 10-14 in each period
Total excretion of fecal fat (grams/day)avaraged over five days
3 secondary outcomes
Total, HDL and LDL cholesterol
Time frame: Day 1 and 14 in each period
Triglycerides
Time frame: Day 1 and 14 in each period
Appetite sensation
Time frame: Assessed on day 1, 8 and 14 in each period
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 5 Sep 2014.
- Derived from this study: PubMed 24622806Soerensen KV, Thorning TK, Astrup A, Kristensen M, Lorenzen JK. Effect of dairy calcium from cheese and milk on fecal fat excretion, blood lipids, and appetite in young men. Am J Clin Nutr. 2014 May;99(5):984-91. doi: 10.3945/ajcn.113.077735. Epub 2014 Mar 12.
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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.
Arne Astrup, Dr med principal investigator
University 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 Dietary intervention (without dairy products), Dietary intervention (high milk content) and Dietary intervention (high cheese content) 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 2 inclusion and 7 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 5 Sep 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: During day 10-14 in each period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01317251, which also lists 1 linked publication.
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 5 Sep 2014.