Nutritional Evaluation of Canola Protein in Comparison With Soy Protein

NCT ID: NCT01481584

Last Updated: 2015-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-11-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Men

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SCREENING

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Canola protein

Canola protein (Brassica juncea; incorporated in a drink)

Group Type EXPERIMENTAL

Protein drink - protein isolate

Intervention Type DIETARY_SUPPLEMENT

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.

Protein drink - protein hydrolyzate

Intervention Type DIETARY_SUPPLEMENT

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.

Reference protein

Reference Protein (soy protein isolate; incorporated in a drink)

Group Type ACTIVE_COMPARATOR

Protein drink - protein isolate

Intervention Type DIETARY_SUPPLEMENT

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.

Protein drink - protein hydrolyzate

Intervention Type DIETARY_SUPPLEMENT

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.

Wash out

Wash out (four weeks without any intervention between interventional periods)

Group Type NO_INTERVENTION

No interventions assigned to this group

Run-in

Run-in period (three days before intervention, defined diet)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type 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.

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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CPI CPH

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Intake of pharmaceuticals
* Allergy against canola protein or soy protein
* Kidney disease
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Gerhard Jahreis

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gerhard Jahreis, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology

Locations

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Friedrich Schiller University Jena, Department of Nutritional Physiology

Jena, Thuringia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 23260747 (View on PubMed)

Other Identifiers

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LSEP H43-10

Identifier Type: -

Identifier Source: org_study_id

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