Healthy Men and WomenNCT01643265
Effect of Whey and Albumin Protein on Plasma Levels of Amino Acids
A study testing Whey Milk Protein and Bovine Albumin Concentrate in people with Healthy Men and Women, run by Metabolic Technologies Inc. at 1 site in United States.
Trial summary
The purpose of this study will allow us to examine how quickly and to what extent plasma amino acids levels rise after ingesting a single dose of either whey or albumin protein. The investigators anticipate that the amino acids from albumin concentrate protein will rise as quickly and to the same extent as amino acids… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Men and Women
- What is being tested?
- Whey Milk Protein and Bovine Albumin Concentrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- normal Healthy volunteers
- free of serious illness/disease such as hypertension, kidney or liver disease
Who cannot join
- taking dietary protein or amino acid supplements
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study will allow us to examine how quickly and to what extent plasma amino acids levels rise after ingesting a single dose of either whey or albumin protein. The investigators anticipate that the amino acids from albumin concentrate protein will rise as quickly and to the same extent as amino acids from whey protein. These findings will help us to understand the biological availability of these proteins and efficacy of the supplement so that consumers may be presented with nutritional options.
- Conditions
- Healthy Men and Women
- Being tested
- Whey Milk Protein, Bovine Albumin Concentrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whey Milk ProteinDietary supplement
20 grams of Whey Milk Protein
Bovine Albumin ConcentrateDietary supplement
20 grams of Bovine Albumin Concentrate
| Study group | Role | What they receive |
|---|---|---|
| Whey Milk Protein | Active comparator | Not described Receives: Dietary Supplement: Whey Milk Protein |
| Bovine Albumin Concentrate | Experimental | Not described Receives: Dietary Supplement: Bovine Albumin Concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amino acid concentration
Measured: 210 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Men and WomenStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Metabolic Technologies Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rick Sharp, PhD, Principal investigator, Iowa State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643265
- Sponsor's protocol ID
- MTI2012-CS02
- Status last verified
- Feb 2013
- First submitted
- 16 Jul 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Whey and Albumin Protein on Plasma Levels of Amino Acids
- ClinicalTrials.gov ID
- NCT01643265
- Acronym / sponsor ID
- MTI2012-CS02
- Conditions
- Healthy Men and Women
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Metabolic Technologies Inc.Industry (pharma, biotech, devices)
- Study start
- Jul 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 18 Jul 2012 (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 purpose of this study will allow us to examine how quickly and to what extent plasma amino acids levels rise after ingesting a single dose of either whey or albumin protein. The investigators anticipate that the amino acids from albumin concentrate protein will rise as quickly and to the same extent as amino acids from whey protein. These findings will help us to understand the biological availability of these proteins and efficacy of the supplement so that consumers may be presented with nutritional options.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whey Milk Protein | Active comparator | Dietary Supplement: Whey Milk Protein |
| Bovine Albumin Concentrate | Experimental | Dietary Supplement: Bovine Albumin Concentrate |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- normal Healthy volunteers
- free of serious illness/disease such as hypertension, kidney or liver disease
Key exclusion criteria (1 listed)
- taking dietary protein or amino acid supplements
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 Milk Protein20 grams of Whey Milk Protein | Dietary supplement | Whey Milk Protein |
| Bovine Albumin Concentrate20 grams of Bovine Albumin Concentrate | Dietary supplement | Bovine Albumin Concentrate |
Primary outcome
Amino acid concentration
Time frame: 210 minutes
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 15 Feb 2013.
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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.
Rick Sharp, PhD principal investigator
Iowa State University
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 Milk Protein and Bovine Albumin Concentrate in people with Healthy Men and Women, run by Metabolic Technologies Inc. at 1 site in United States.
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 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 15 Feb 2013. 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 United States. 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?
Amino acid concentration (time frame: 210 minutes). 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 15 Feb 2013.