ObesityMAESNCT01133964
Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure
A study testing dairy proteins in people with Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of this study is to examine the effect of dairy proteins (whey and casein) on postprandial appetite regulation and energy expenditure. 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 proteins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2008to Dec 2009
- 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
- body mass index (BMI) 25-30 kg/m2
- 18-50 years
- weight stable
Who cannot join
- smoker
- regular use of medicine
- elitist athletes
- participation in other intervention studies
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department og Human Nutrition, Life, University of Copenhagen
Copenhagen, 1958
About this study
The aim of this study is to examine the effect of dairy proteins (whey and casein) on postprandial appetite regulation and energy expenditure.
Read the detailed description
Several studies have shown that a high protein intake is associated with a increased loss of body weight and body fat as compared to a diet with a normal or low protein content. The effect seems to be due to a higher diet induced thermogenesis and increase satiety.
Milk has a high content of proteins. It contains two very different types of protein: whey and casein. Whey is a soluble protein whereas casein clots into the stomach, which delays its gastric emptying and thus probably results in a slower release of amino acids. It is therefore very likely that the two types of protein affect the thermogenesis and appetite regulation differently.
The aim of the present study is to examine the effect of dairy proteins (whey and casein) on postprandial energy expenditure, substrate oxidation and appetite regulation.
The study will have a cross-over design including four meals each including a test drink (milk, casein drink, whey drink or water).
- Conditions
- Obesity
- Being tested
- dairy proteins
- Keywords
- Dairy proteins, Appetite regulation, Energy expenditure
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dairy proteinsDietary supplement
Protein drinks with 3.5% protein. The protein source will be whey, casein or whey and casein (20:80; normal content in the milk). In the arm with water no protein will be added.
| Study group | Role | What they receive |
|---|---|---|
| milk | Experimental | skim milk Receives: Dietary Supplement: dairy proteins |
| casein drink | Experimental | Not described Receives: Dietary Supplement: dairy proteins |
| whey drink | Experimental | Not described Receives: Dietary Supplement: dairy proteins |
| water | Sham comparator | Not described Receives: Dietary Supplement: dairy proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective appetite sensation
Measured: 5 hours
Energy expenditure
Measured: 5 hours
Substrate oxidation
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2010 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionDec 2009
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
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Investigators
- Arne Astrup, Dr., Principal investigator, Department of Human Nutrition, Life, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01133964
- Sponsor's protocol ID
- B256
- Acronym
- MAES
- Status last verified
- Sep 2008
- First submitted
- 27 May 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dairy Proteins and Postprandial Appetite Regulation and Energy Expenditure
- ClinicalTrials.gov ID
- NCT01133964
- Acronym / sponsor ID
- MAES / B256
- Conditions
- Obesity
- Keywords
- Dairy proteins, Appetite regulation, Energy expenditure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 31 May 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 this study is to examine the effect of dairy proteins (whey and casein) on postprandial appetite regulation and energy expenditure.
Detailed description
Several studies have shown that a high protein intake is associated with a increased loss of body weight and body fat as compared to a diet with a normal or low protein content. The effect seems to be due to a higher diet induced thermogenesis and increase satiety.
Milk has a high content of proteins. It contains two very different types of protein: whey and casein. Whey is a soluble protein whereas casein clots into the stomach, which delays its gastric emptying and thus probably results in a slower release of amino acids. It is therefore very likely that the two types of protein affect the thermogenesis and appetite regulation differently.
The aim of the present study is to examine the effect of dairy proteins (whey and casein) on postprandial energy expenditure, substrate oxidation and appetite regulation.
The study will have a cross-over design including four meals each including a test drink (milk, casein drink, whey drink or water).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| milk | Experimental | Dietary Supplement: dairy proteinsskim milk |
| casein drink | Experimental | Dietary Supplement: dairy proteins |
| whey drink | Experimental | Dietary Supplement: dairy proteins |
| water | Sham comparator | Dietary Supplement: dairy proteins |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- healthy males
- body mass index (BMI) 25-30 kg/m2
- 18-50 years
- weight stable
Key exclusion criteria (4 listed)
- smoker
- regular use of medicine
- elitist athletes
- participation in other intervention studies
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 proteinsProtein drinks with 3.5% protein. The protein source will be whey, casein or whey and casein (20:80; normal content in the milk). In the arm with water no protein will be added. | Dietary supplement | casein drink, milk, water, whey drink |
Primary outcome
Subjective appetite sensation
Time frame: 5 hours
Energy expenditure
Time frame: 5 hours
Substrate oxidation
Time frame: 5 hours
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 27 Jun 2011.
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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. principal investigator
Department of Human Nutrition, Life, 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 dairy proteins 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 4 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 27 Jun 2011. 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. Some participants in this study may receive a placebo. 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?
Subjective appetite sensation (time frame: 5 hours). 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 27 Jun 2011.