Nutritional Evaluation of Canola Protein in Comparison With Soy Protein

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comparison of the Bioavailability the of a Single Administration of Two Canola Proteins (Hydrolyzate, Isolate) and Soy Protein in Healthy Men.

Conditions
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Men

Intervention / Treatment
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* Dietary Supplement: Protein drink - protein isolate
* Dietary Supplement: Protein drink - protein hydrolyzate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Nonsmoker Body mass index: 20-26 kg/m² Exclusion Criteria: Intake of pharmaceuticals Allergy against canola protein or soy protein Kidney disease

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Canola protein<br>Canola protein (Brassica juncea; incorporated in a drink) | Dietary Supplement: Protein drink - protein isolate<br>* 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.<br>* Other names: CPI;Dietary Supplement: Protein drink - protein hydrolyzate<br>* 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.<br>* Other names: CPH;|
| Active Comparator: Reference protein<br>Reference Protein (soy protein isolate; incorporated in a drink) | Dietary Supplement: Protein drink - protein isolate<br>* 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.<br>* Other names: CPI;Dietary Supplement: Protein drink - protein hydrolyzate<br>* 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.<br>* Other names: CPH;|
| No Intervention: Wash out<br>Wash out (four weeks without any intervention between interventional periods) | |
| No Intervention: Run-in<br>Run-in period (three days before intervention, defined diet) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma amino acids | Free proteinogenic amino acids | At Day 1 (Intervention day); After 0, 30, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition (body status) | Bioelectrical impedance analysis, body weight | 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 | After day 0 and 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dietary protein, Canola protein, Protein metabolism, Protein-enriched drinks, Nitrogen balance