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.

Study Overview

• Status: Completed
• Conditions: Men
• Intervention / Treatment: Dietary supplement: Protein drink - protein isolate; Dietary supplement: Protein drink - protein hydrolyzate

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
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Thuringia
    • Jena, Thuringia, Germany, 07743
      • Friedrich Schiller University Jena, Department of Nutritional Physiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Jena

Publications and helpful links

General Publications

• Fleddermann M, Fechner A, Rossler A, Bahr M, Pastor A, Liebert F, Jahreis G. Nutritional evaluation of rapeseed protein compared to soy protein for quality, plasma amino acids, and nitrogen balance--a randomized cross-over intervention study in humans. Clin Nutr. 2013 Aug;32(4):519-26. doi: 10.1016/j.clnu.2012.11.005. Epub 2012 Nov 14.

Study record dates

Study Major Dates

• Study Start: May 1, 2010
• Primary Completion (ACTUAL): July 1, 2010
• Study Completion (ACTUAL): November 1, 2011

Study Registration Dates

• First Submitted: November 24, 2011
• First Submitted That Met QC Criteria: November 24, 2011
• First Posted (ESTIMATE): November 29, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): March 5, 2015
• Last Update Submitted That Met QC Criteria: March 4, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Dietary protein; Protein metabolism; Protein-enriched drinks; Canola protein; Nitrogen balance
• Other Study ID Numbers: LSEP H43-10