HealthyProFNCT00621231
The Protein (Meat) and Function Study
A study testing Protein in people with Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The aim of the proposed study is to investigate the effects of different amounts of protein intake primarily from meat on muscle function, immune response, mental function, proteomics, biochemical regulators of protein metabolism, energy expenditure, and composition in young healthy males. Read more about this study
- Who is it for?
- Ages 19 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Protein
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- Not given
- Where
- 1 siteDenmark
- Study dates
- Sep 2007to Apr 2008
- 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 19 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy males, 19-40 y/o
Who cannot join
- Smokers
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of human nutrition
Copenhagen, DK-Frederiksberg C, 1958
About this study
Official title: Effect of Normal Versus High Amounts of Protein Intake on Physiological Functions and Proteomics in Healthy Men
The aim of the proposed study is to investigate the effects of different amounts of protein intake primarily from meat on muscle function, immune response, mental function, proteomics, biochemical regulators of protein metabolism, energy expenditure, and composition in young healthy males.
- Conditions
- Healthy
- Being tested
- Placebo, Protein
- Keywords
- Protein Function, normal versus high protein intake
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Placebo
ProteinDietary supplement
30 E% from protein
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
| 2 | Experimental | Not described Receives: Dietary Supplement: Protein |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startSep 2007
- Primary completionDec 2007
- Study completionApr 2008
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 HealthyStudies 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
- Basic science
- Intervention model
- Parallel groups
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00621231
- Sponsor's protocol ID
- K101
- Acronym
- ProF
- Status last verified
- May 2007
- First submitted
- 12 Feb 2008
- Last updated
- 22 Feb 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
Jakobsen LH, Kondrup J, Zellner M, Tetens I, Roth E. Effect of a high protein meat diet on muscle and cognitive functions: a randomised controlled dietary intervention trial in healthy men. Clin Nutr. 2011 Jun;30(3):303-11. doi: 10.1016/j.clnu.2010.12.010. Epub 2011 Jan 15.
PubMed 21239090
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Normal Versus High Amounts of Protein Intake on Physiological Functions and Proteomics in Healthy Men
- ClinicalTrials.gov ID
- NCT00621231
- Acronym / sponsor ID
- ProF / K101
- Conditions
- Healthy
- Keywords
- Protein Function, normal versus high protein intake
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Dec 2007 (actual)
- Study completion
- Apr 2008
- First posted
- 22 Feb 2008 (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 proposed study is to investigate the effects of different amounts of protein intake primarily from meat on muscle function, immune response, mental function, proteomics, biochemical regulators of protein metabolism, energy expenditure, and composition in young healthy males.
Study design
- Primary purpose
- Basic science
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: Placebo |
| 2 | Experimental | Dietary Supplement: Protein |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy males, 19-40 y/o
Key exclusion criteria (1 listed)
- Smokers
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 |
|---|---|---|
| PlaceboPlacebo | Dietary supplement | 1 |
| Protein30 E% from protein | Dietary supplement | 2 |
Primary outcome
Not reported in the source record.
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 22 Feb 2008.
- Derived from this study: PubMed 21239090Jakobsen LH, Kondrup J, Zellner M, Tetens I, Roth E. Effect of a high protein meat diet on muscle and cognitive functions: a randomised controlled dietary intervention trial in healthy men. Clin Nutr. 2011 Jun;30(3):303-11. doi: 10.1016/j.clnu.2010.12.010. Epub 2011 Jan 15.
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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 Protein in people with Healthy, 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 1 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 22 Feb 2008. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00621231, 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 22 Feb 2008.