Nutritional Evaluation of Canola Protein in Comparison With Soy Protein

Study Description

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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 Design

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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)

Outcome Measures

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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

Eligibility Criteria

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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

Contacts and Locations

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Fleddermann M, Fechner A, Rößler A, Bähr 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.

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
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