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
  Purpose

The objective of the study is to evaluate the nutritional and physiological properties of two canola proteins focusing on the bioavailability in humans.


Condition Intervention
Men
Dietary Supplement: Protein drink - protein isolate
Dietary Supplement: Protein drink - protein hydrolyzate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Further study details as provided by University of Jena:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 28
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   20 Years to 35 Years
Genders 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by University of Jena

Additional 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
Study First Received: November 24, 2011
Last Updated: November 24, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University of Jena:
Dietary protein
Canola protein
Protein metabolism
Protein-enriched drinks
Nitrogen balance

ClinicalTrials.gov processed this record on August 27, 2014