Clinical trial NCT01481584: Nutritional Evaluation of Canola Protein in Comparison With Soy Protein
Official title: Comparison of the Bioavailability the of a Single Administration of Two Canola Proteins (Hydrolyzate, Isolate) and Soy Protein in Healthy Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Men
Keywords: Dietary protein
Canola protein
Protein metabolism
Protein-enriched drinks
Nitrogen balance
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 28
Sex: MALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SCREENING

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.

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 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

Primary outcomes:
measure: Plasma amino acids
timeFrame: At Day 1 (Intervention day); After 0, 30, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes
Secondary outcomes:
measure: Body composition (body status)
timeFrame: At day 1
measure: Nitrogen balance
timeFrame: After day 0 and 1
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Friedrich Schiller University Jena, Department of Nutritional Physiology
state: Thuringia
Study officials:
affiliation: Friedrich Schiller University Jena, Institute of Nutrition, Department of Nutritional Physiology
name: Gerhard Jahreis, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.