Metabolic SyndromeNCT00378820
The Effect of Whey and Casein on IGFs in Prepubertal Boys
A study testing Whey without milk minerals, Whey with milk minerals and Casein without milk minerals in people with Metabolic Syndrome and Obesity, run by University of Copenhagen at 1 site in Denmark.
Trial summary
It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Read more about this study
- Who is it for?
- Ages 8 to 8 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Syndrome, Obesity
- What is being tested?
- Whey without milk minerals, Whey with milk minerals and Casein without milk minerals
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jul 2004to Apr 2005
- 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 8 to 8 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- habital milk intake:200 - 500 mL/d
Who cannot join
- chronic illnesses
- children who suffer from any condition likely to affect their protein metabolism or growth
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Institute of Human Nutrition, Rolighedsvej 30
Frederiksberg C, 1958
About this study
Official title: The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys
It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure.
Read the detailed description
Milk has evolved to support high growth velocity in newborns and observational and intervention studies suggest that milk has special growth stimulating properties especially regarding body size, bone mass and gut. We have previously shown that a one week high-dose intervention with milk, but not meat, increased fasting IGF-I and insulin levels in prepubertal boys. It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure. Exploring the growth stimulating effects of these milk components will improve the understanding of dietary effects on growth and bone metabolism, and will be valuable for the diary industry developing dietary products supporting growth e.g. infant formula, products for clinical nutrition and milk based products for nutritional rehabilitation of malnourished children in developing countries.
- Conditions
- Metabolic Syndrome, Obesity
- Being tested
- Whey without milk minerals, Whey with milk minerals, Casein without milk minerals, Casein with milk minerals
- Keywords
- Children, Whey, Casein, Milk minerals, Growth factors, IGF-I, Insulin
- Medical subject headings
- Metabolic Syndrome, Obesity, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey without milk mineralsBehavioural
Whey with milk mineralsBehavioural
Casein without milk mineralsBehavioural
Casein with milk mineralsBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-I
IGFBP-3
Insulin
Glucose
Secondary outcomes (12)
Blood Pressure
Body Composition
Adiponectin
Leptin
Ghrelin
C-peptide
OGGT
Urea Nitrogen
Amino Acids
Osteocalcin
BAP
CTX
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startJul 2004
- Study completionApr 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies 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
- Factorial
- Masking
- Double blind
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Arla Foods
- Investigators
- Kim F Michaelsen, Dr Med Sci, Study chair, Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00378820
- Sponsor's protocol ID
- KF 01-072/04
- Other IDs
- D-111
- Status last verified
- Sep 2006
- First submitted
- 20 Sep 2006
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Whey and Casein With and Without Milk Minerals on IGFs in Prepubertal Boys
- ClinicalTrials.gov ID
- NCT00378820
- Acronym / sponsor ID
- KF 01-072/04
- Conditions
- Metabolic Syndrome, Obesity
- Keywords
- Children, Whey, Casein, Milk minerals, Growth factors, IGF-I, Insulin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Arla Foods
- Study start
- Jul 2004
- Study completion
- Apr 2005
- First posted
- 21 Sep 2006 (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.
It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure.
Detailed description
Milk has evolved to support high growth velocity in newborns and observational and intervention studies suggest that milk has special growth stimulating properties especially regarding body size, bone mass and gut. We have previously shown that a one week high-dose intervention with milk, but not meat, increased fasting IGF-I and insulin levels in prepubertal boys. It is not clear which milk compounds are responsible for the growth stimulation. Through short term intervention studies in prepubertal children, we will test the effects of whey, casein, and milk minerals (especially Ca/P). Outcomes will be IGF-I, IGFBP-3, p-amino acids, oral glucose tolerance test (insulin, glucose, GLP-1 and 2, C-peptide, proinsulin) and markers for bone turn-over in blood and urine (s-osteocalcin, s-bone alkaline phosphatase, urine Dpyr, Ntx) as well as blood pressure. Exploring the growth stimulating effects of these milk components will improve the understanding of dietary effects on growth and bone metabolism, and will be valuable for the diary industry developing dietary products supporting growth e.g. infant formula, products for clinical nutrition and milk based products for nutritional rehabilitation of malnourished children in developing countries.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
Who may qualify
- Ages
- 8 to 8 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- habital milk intake:200 - 500 mL/d
Key exclusion criteria (2 listed)
- chronic illnesses
- children who suffer from any condition likely to affect their protein metabolism or growth
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 |
|---|---|---|
| Whey without milk minerals | Behavioural | – |
| Whey with milk minerals | Behavioural | – |
| Casein without milk minerals | Behavioural | – |
| Casein with milk minerals | Behavioural | – |
Primary outcome
IGF-I
IGFBP-3
Insulin
Glucose
12 secondary outcomes
Blood Pressure
Body Composition
Adiponectin
Leptin
Ghrelin
C-peptide
OGGT
Urea Nitrogen
Amino Acids
Osteocalcin
BAP
CTX
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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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.
Kim F Michaelsen, Dr Med Sci study chair
Institute of Human Nutrition, Rolighedsvej 30, DK-1958 Frederiksberg C, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whey without milk minerals, Whey with milk minerals and Casein without milk minerals in people with Metabolic Syndrome and 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 1 inclusion and 2 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 21 Jan 2009. 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?
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?
IGF-I. The study lists 4 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 21 Jan 2009.