Nutritional Evaluation of Canola Protein in Comparison With Soy Protein
| Tracking Information | |||||
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| First Received Date ICMJE | November 24, 2011 | ||||
| Last Updated Date | November 24, 2011 | ||||
| Start Date ICMJE | May 2010 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Plasma amino acids [ Time Frame: At Day 1 (Intervention day); After 0, 30, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes ] [ Designated as safety issue: Yes ] Free proteinogenic amino acids |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Nutritional Evaluation of Canola Protein in Comparison With Soy Protein | ||||
| Official Title ICMJE | Comparison of the Bioavailability the of a Single Administration of Two Canola Proteins (Hydrolyzate, Isolate) and Soy Protein in Healthy Men. | ||||
| Brief Summary | The objective of the study is to evaluate the nutritional and physiological properties of two canola proteins focusing on the bioavailability in humans. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Screening |
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| Condition ICMJE | Men | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 28 | ||||
| Completion Date | November 2011 | ||||
| Primary Completion Date | July 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Male | ||||
| Ages | 20 Years to 35 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01481584 | ||||
| Other Study ID Numbers ICMJE | LSEP H43-10 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Gerhard Jahreis, University of Jena | ||||
| Study Sponsor ICMJE | University of Jena | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Jena | ||||
| Verification Date | November 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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