Nutritional Evaluation of Canola Protein in Comparison With Soy Protein

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01481584

First Posted: November 29, 2011

Last Update Posted: March 5, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Gerhard Jahreis, University of Jena

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 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.

Further study details as provided by Gerhard Jahreis, 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 ]
Free proteinogenic amino acids

Secondary Outcome Measures:

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


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

Information from the National Library of Medicine

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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

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

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 Submitted:	November 24, 2011
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

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