MenNCT01481584
Nutritional Evaluation of Canola Protein in Comparison With Soy Protein
A study testing Protein drink - protein isolate and Protein drink - protein hydrolyzate in people with Men, run by University of Jena at 1 site in Germany.
Trial summary
The objective of the study is to evaluate the nutritional and physiological properties of two canola proteins focusing on the bioavailability in humans. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Men
- What is being tested?
- Protein drink - protein isolate and Protein drink - protein hydrolyzate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteGermany
- Study dates
- May 2010to Nov 2011
- 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 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Nonsmoker
- Body mass index: 20-26 kg/m²
Who cannot join
- Intake of pharmaceuticals
- Allergy against canola protein or soy protein
- Kidney disease
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, 07743
About this study
Official title: Comparison of the Bioavailability the of a Single Administration of Two Canola Proteins (Hydrolyzate, Isolate) and Soy Protein in Healthy Men.
The objective of the study is to evaluate the nutritional and physiological properties of two canola proteins focusing on the bioavailability in humans.
Read the detailed description
The physiological effects of a single administration of two different industrially manufactured canola proteins (hydrolyzate, isolate) were investigated compared to soy protein.
Twenty-eight healthy men (ø 25 years) completed a double-blind, placebo-controlled, crossover study. The subjects were randomly divided into two groups (group A: canola protein isolate and soy protein isolate and group B: canola protein hydrolyzate and soy protein isolate). After a three-day run-in period, on the intervention day, the subjects consumed a protein drink containing 30.0 g protein powder added to a final volume of 500 mL tomato juice. Half of the subjects in each group consumed a protein drink containing 30.0 g canola protein, the other half received the soy protein. After taking of fasting blood samples in the morning of the intervention day, blood samples were drawn at regular intervals for a period of eight hours. At the end of the run-in period and on the intervention day, a 24-hour urine collection took place.
Within a second experiment (after 4 weeks), the protein source was crossed within the four subgroups for the second intervention.
- Conditions
- Men
- Being tested
- Protein drink - protein isolate, Protein drink - protein hydrolyzate
- Keywords
- Dietary protein, Canola protein, Protein metabolism, Protein-enriched drinks, Nitrogen balance
- Medical subject headings
- Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Protein drink - protein isolateDietary supplement
Also called CPI
The subjects consumed 500 mL of a protein drink (tomato juice) containing 30 g protein (canola protein isolate or reference protein) after overnight fasting. After run-in period, each volunteer have to pass both protein-intervention days in different order with a four-week wash out period in between.
Protein drink - protein hydrolyzateDietary supplement
Also called CPH
The subjects consumed 500 mL of a protein drink (tomato juice) containing 30 g protein (canola protein hydrolyzate or reference protein) after overnight fasting. After run-in period, each volunteer have to pass both protein-intervention days in different order with a four-week wash out period in between.
| Study group | Role | What they receive |
|---|---|---|
| Canola protein | Experimental | Canola protein (Brassica juncea; incorporated in a drink) Receives: Dietary Supplement: Protein drink - protein isolate; Dietary Supplement: Protein drink - protein hydrolyzate |
| Reference protein | Active comparator | Reference Protein (soy protein isolate; incorporated in a drink) Receives: Dietary Supplement: Protein drink - protein isolate; Dietary Supplement: Protein drink - protein hydrolyzate |
| Wash out | No intervention | Wash out (four weeks without any intervention between interventional periods) |
| Run-in | No intervention | Run-in period (three days before intervention, defined diet) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acids
Free proteinogenic amino acids
Measured: At Day 1 (Intervention day); After 0, 30, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes
Secondary outcomes (2)
Body composition (body status)
Bioelectrical impedance analysis, body weight
Measured: At day 1
Nitrogen balance
Nitrogen balance = nitrogen intake - nitrogen output (urine nitrogen + fecal nitrogen + skin nitrogen); Nitrogen intake was calculated from food uptake; Urine nitrogen contains urea, uric acid, creatinine and total protein; Fecal nitrogen was calculated as the tenth part of the nitrogen intake; Skin nitrogen was calculated as 5.00 mg per kg of body weight
Measured: After day 0 and 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study startMay 2010
- Primary completionJul 2010
- Study completionNov 2011
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 MenStudies 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
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Jahreis, University of Jena
- Investigators
- Gerhard Jahreis, Prof. Dr., Principal investigator, Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01481584
- Sponsor's protocol ID
- LSEP H43-10
- Status last verified
- Mar 2015
- First submitted
- 24 Nov 2011
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fleddermann M, Fechner A, Rossler A, Bahr M, Pastor A, Liebert F, Jahreis G. Nutritional evaluation of rapeseed protein compared to soy protein for quality, plasma amino acids, and nitrogen balance--a randomized cross-over intervention study in humans. Clin Nutr. 2013 Aug;32(4):519-26. doi: 10.1016/j.clnu.2012.11.005. Epub 2012 Nov 14.
PubMed 23260747
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Bioavailability the of a Single Administration of Two Canola Proteins (Hydrolyzate, Isolate) and Soy Protein in Healthy Men.
- ClinicalTrials.gov ID
- NCT01481584
- Acronym / sponsor ID
- LSEP H43-10
- Conditions
- Men
- Keywords
- Dietary protein, Canola protein, Protein metabolism, Protein-enriched drinks, Nitrogen balance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 29 Nov 2011 (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 evaluate the nutritional and physiological properties of two canola proteins focusing on the bioavailability in humans.
Detailed description
The physiological effects of a single administration of two different industrially manufactured canola proteins (hydrolyzate, isolate) were investigated compared to soy protein.
Twenty-eight healthy men (ø 25 years) completed a double-blind, placebo-controlled, crossover study. The subjects were randomly divided into two groups (group A: canola protein isolate and soy protein isolate and group B: canola protein hydrolyzate and soy protein isolate). After a three-day run-in period, on the intervention day, the subjects consumed a protein drink containing 30.0 g protein powder added to a final volume of 500 mL tomato juice. Half of the subjects in each group consumed a protein drink containing 30.0 g canola protein, the other half received the soy protein. After taking of fasting blood samples in the morning of the intervention day, blood samples were drawn at regular intervals for a period of eight hours. At the end of the run-in period and on the intervention day, a 24-hour urine collection took place.
Within a second experiment (after 4 weeks), the protein source was crossed within the four subgroups for the second intervention.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Canola protein | Experimental | Dietary Supplement: Protein drink - protein isolate, Dietary Supplement: Protein drink - protein hydrolyzateCanola protein (Brassica juncea; incorporated in a drink) |
| Reference protein | Active comparator | Dietary Supplement: Protein drink - protein isolate, Dietary Supplement: Protein drink - protein hydrolyzateReference Protein (soy protein isolate; incorporated in a drink) |
| Wash out | No intervention | –Wash out (four weeks without any intervention between interventional periods) |
| Run-in | No intervention | –Run-in period (three days before intervention, defined diet) |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Nonsmoker
- Body mass index: 20-26 kg/m²
Key exclusion criteria (3 listed)
- Intake of pharmaceuticals
- Allergy against canola protein or soy protein
- Kidney disease
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 |
|---|---|---|
| Protein drink - protein isolateAlso: CPIThe subjects consumed 500 mL of a protein drink (tomato juice) containing 30 g protein (canola protein isolate or reference protein) after overnight fasting. After run-in period, each volunteer have to pass both protein-intervention days in different order with a four-week wash out period in between. | Dietary supplement | Canola protein, Reference protein |
| Protein drink - protein hydrolyzateAlso: CPHThe subjects consumed 500 mL of a protein drink (tomato juice) containing 30 g protein (canola protein hydrolyzate or reference protein) after overnight fasting. After run-in period, each volunteer have to pass both protein-intervention days in different order with a four-week wash out period in between. | Dietary supplement | Canola protein, Reference protein |
Primary outcome
Plasma amino acids
Time frame: At Day 1 (Intervention day); After 0, 30, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes
Free proteinogenic amino acids
2 secondary outcomes
Body composition (body status)
Time frame: At day 1
Nitrogen balance
Time frame: After day 0 and 1
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 5 Mar 2015.
- Derived from this study: PubMed 23260747Fleddermann M, Fechner A, Rossler A, Bahr M, Pastor A, Liebert F, Jahreis G. Nutritional evaluation of rapeseed protein compared to soy protein for quality, plasma amino acids, and nitrogen balance--a randomized cross-over intervention study in humans. Clin Nutr. 2013 Aug;32(4):519-26. doi: 10.1016/j.clnu.2012.11.005. Epub 2012 Nov 14.
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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.
Gerhard Jahreis, Prof. Dr. principal investigator
Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
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 drink - protein isolate and Protein drink - protein hydrolyzate in people with Men, run by University of Jena at 1 site in Germany.
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 3 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 5 Mar 2015. 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 Germany. 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?
Plasma amino acids (time frame: At Day 1 (Intervention day); After 0, 30, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01481584, 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 5 Mar 2015.