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Nutritional Evaluation of Canola Protein in Comparison With Soy Protein

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ClinicalTrials.gov Identifier: NCT01481584
Recruitment Status : Completed
First Posted : November 29, 2011
Last Update Posted : March 5, 2015
Sponsor:
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena

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.

Condition or disease Intervention/treatment Phase
Men Dietary Supplement: Protein drink - protein isolate Dietary Supplement: Protein drink - protein hydrolyzate Not Applicable

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 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
Experimental: Canola protein
Canola protein (Brassica juncea; incorporated in a drink)
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

Active Comparator: Reference protein
Reference Protein (soy protein isolate; incorporated in a drink)
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

No Intervention: Wash out
Wash out (four weeks without any intervention between interventional periods)
No Intervention: Run-in
Run-in period (three days before intervention, defined diet)



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Body composition (body status) [ Time Frame: At day 1 ]
    Bioelectrical impedance analysis, body weight

  2. 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
Criteria

Inclusion Criteria:

  • Nonsmoker
  • Body mass index: 20-26 kg/m²

Exclusion Criteria:

  • Intake of pharmaceuticals
  • Allergy against canola protein or soy protein
  • Kidney disease

Information from the National Library of Medicine

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


Locations
Germany
Friedrich Schiller University Jena, Department of Nutritional Physiology
Jena, Thuringia, Germany, 07743
Sponsors and Collaborators
University of Jena
Investigators
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:
Dietary protein
Canola protein
Protein metabolism
Protein-enriched drinks
Nitrogen balance