Nutritional Evaluation of Canola Protein in Comparison With Soy Protein
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| ClinicalTrials.gov Identifier: NCT01481584 |
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Recruitment Status :
Completed
First Posted : November 29, 2011
Last Update Posted : March 5, 2015
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Men | Dietary Supplement: Protein drink - protein isolate Dietary Supplement: Protein drink - protein hydrolyzate | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 28 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Screening |
| Official Title: | Comparison of the Bioavailability the of a Single Administration of Two Canola Proteins (Hydrolyzate, Isolate) and Soy Protein in Healthy Men. |
| Study Start Date : | May 2010 |
| Actual Primary Completion Date : | July 2010 |
| Actual Study Completion Date : | November 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Canola protein
Canola protein (Brassica juncea; incorporated in a drink)
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Dietary Supplement: Protein drink - protein isolate
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.
Other Name: CPI Dietary Supplement: Protein drink - protein hydrolyzate 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.
Other Name: CPH |
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Active Comparator: Reference protein
Reference Protein (soy protein isolate; incorporated in a drink)
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Dietary Supplement: Protein drink - protein isolate
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.
Other Name: CPI Dietary Supplement: Protein drink - protein hydrolyzate 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.
Other Name: CPH |
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No Intervention: Wash out
Wash out (four weeks without any intervention between interventional periods)
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No Intervention: Run-in
Run-in period (three days before intervention, defined diet)
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- 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
- Body composition (body status) [ Time Frame: At day 1 ]Bioelectrical impedance analysis, body weight
- Nitrogen balance [ Time Frame: After day 0 and 1 ]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
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| Ages Eligible for Study: | 20 Years to 35 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Nonsmoker
- Body mass index: 20-26 kg/m²
Exclusion Criteria:
- Intake of pharmaceuticals
- Allergy against canola protein or soy protein
- Kidney disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01481584
| Germany | |
| Friedrich Schiller University Jena, Department of Nutritional Physiology | |
| Jena, Thuringia, Germany, 07743 | |
| Principal Investigator: | Gerhard Jahreis, Prof. Dr. | Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Gerhard Jahreis, Prof. Dr., University of Jena |
| ClinicalTrials.gov Identifier: | NCT01481584 History of Changes |
| Other Study ID Numbers: |
LSEP H43-10 |
| First Posted: | November 29, 2011 Key Record Dates |
| Last Update Posted: | March 5, 2015 |
| Last Verified: | March 2015 |
Keywords provided by Gerhard Jahreis, University of Jena:
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Dietary protein Canola protein Protein metabolism Protein-enriched drinks Nitrogen balance |