Nutritional Evaluation of Canola Protein in Comparison With Soy Protein

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gerhard Jahreis, University of Jena
ClinicalTrials.gov Identifier:
NCT01481584
First received: November 24, 2011
Last updated: NA
Last verified: November 2011
History: No changes posted

November 24, 2011
November 24, 2011
May 2010
July 2010   (final data collection date for 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 ] [ Designated as safety issue: Yes ]
Free proteinogenic amino acids
Same as current
No Changes Posted
  • Body composition (body status) [ Time Frame: At day 1 ] [ Designated as safety issue: Yes ]
    Bioelectrical impedance analysis, body weight
  • Nitrogen balance [ Time Frame: After day 0 and 1 ] [ Designated as safety issue: Yes ]
    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
Same as current
Not Provided
Not Provided
 
Nutritional Evaluation of Canola Protein in Comparison With Soy Protein
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Screening
Men
  • 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
  • Experimental: Canola protein
    Canola protein (Brassica juncea; incorporated in a drink)
    Interventions:
    • Dietary Supplement: Protein drink - protein isolate
    • Dietary Supplement: Protein drink - protein hydrolyzate
  • Active Comparator: Reference protein
    Reference Protein (soy protein isolate; incorporated in a drink)
    Interventions:
    • Dietary Supplement: Protein drink - protein isolate
    • Dietary Supplement: Protein drink - protein hydrolyzate
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
November 2011
July 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • Intake of pharmaceuticals
  • Allergy against canola protein or soy protein
  • Kidney disease
Male
20 Years to 35 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01481584
LSEP H43-10
Yes
Gerhard Jahreis, University of Jena
University of Jena
Not Provided
Principal Investigator: Gerhard Jahreis, Prof. Dr. Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
University of Jena
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP