Growth DisordersNCT00378859
The Effect of Milk and Meat on IGFs in Prepubertal Boys
A study testing Skim milk and Lean meat in people with Growth Disorders and Metabolic Syndrome, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The objective of the study is to examine whether a 7-day high protein intake from either milk or meat in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids. 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
- Growth Disorders, Metabolic Syndrome
- What is being tested?
- Skim milk and Lean meat
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 24 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2000to Mar 2001
- 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 more than 500 mL/d
- willing to increase intake of milk or meat considerably for one week
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
The objective of the study is to examine whether a 7-day high protein intake from either milk or meat in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids.
Read the detailed description
The objective of the study is to examine whether a high protein intake (PI) from either milk or meat, at a level often seen in late infancy, in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids.
IGF-I levels are positively associated with growth velocity in children and some studies suggest that a high animal PI can stimulate growth. During protein deprivation IGF-I decrease, but it is unknown whether a high PI can increase s-IGF-I in well-nourished children.
Insulin is also a growth factor, and studies have found that postprandially, milk possess some insulinotrophic effect not related to its carbohydrate content. However, the effect on fasting insulin in children is unknown.
Design: Twenty-four 8-y-old boys are asked to take either 1.5 l of skimmed milk (n=12) or the same amount of protein as 250 g low fat meat (n=12) daily for seven days. The remaining diet they can choose freely. At baseline and after seven days, anthropometrical variables are measured, diet is registered (3-d weighed records), and the blood analytes are determined after fast.
- Conditions
- Growth Disorders, Metabolic Syndrome
- Being tested
- Skim milk, Lean meat
- Keywords
- Children, Milk, Meat, Animal Protein, Growth Factors, IGF-I, IGFBP-3, Insulin
- Medical subject headings
- Growth Disorders, Metabolic Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skim milkBehavioural
Lean meatBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
IGF-I
IGFBP-3
Insulin
Glucose
Aminogram
Secondary outcomes (9)
Blood Pressure
Kidney Size
Urea Nitrogen
Adiponectin
Leptin
Ghrelin
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 startNov 2000
- Study completionMar 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth DisordersStudies 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
- 24 participants
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- 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
- NCT00378859
- Sponsor's protocol ID
- KF 01-097/00
- Other IDs
- D-110
- 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 Milk and Meat on IGFs in Prepubertal Boys
- ClinicalTrials.gov ID
- NCT00378859
- Acronym / sponsor ID
- KF 01-097/00
- Conditions
- Growth Disorders, Metabolic Syndrome
- Keywords
- Children, Milk, Meat, Animal Protein, Growth Factors, IGF-I, IGFBP-3, Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Nov 2000
- Study completion
- Mar 2001
- 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.
The objective of the study is to examine whether a 7-day high protein intake from either milk or meat in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids.
Detailed description
The objective of the study is to examine whether a high protein intake (PI) from either milk or meat, at a level often seen in late infancy, in healthy, prepubertal children can increase fasting levels of serum IGF-I, IGFBP-3 and IGF-I/IGFBP-3 as well as insulin, glucose and HOMA insulin reststance, HOMA beta cell function and amino acids.
IGF-I levels are positively associated with growth velocity in children and some studies suggest that a high animal PI can stimulate growth. During protein deprivation IGF-I decrease, but it is unknown whether a high PI can increase s-IGF-I in well-nourished children.
Insulin is also a growth factor, and studies have found that postprandially, milk possess some insulinotrophic effect not related to its carbohydrate content. However, the effect on fasting insulin in children is unknown.
Design: Twenty-four 8-y-old boys are asked to take either 1.5 l of skimmed milk (n=12) or the same amount of protein as 250 g low fat meat (n=12) daily for seven days. The remaining diet they can choose freely. At baseline and after seven days, anthropometrical variables are measured, diet is registered (3-d weighed records), and the blood analytes are determined after fast.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 8 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- habital milk intake more than 500 mL/d
- willing to increase intake of milk or meat considerably for one week
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 |
|---|---|---|
| Skim milk | Behavioural | – |
| Lean meat | Behavioural | – |
Primary outcome
IGF-I
IGFBP-3
Insulin
Glucose
Aminogram
9 secondary outcomes
Blood Pressure
Kidney Size
Urea Nitrogen
Adiponectin
Leptin
Ghrelin
Osteocalcin
BAP
CTX
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 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 Skim milk and Lean meat in people with Growth Disorders and Metabolic Syndrome, 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 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: finished, 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?
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?
IGF-I. The study lists 5 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.