Nutritional Evaluation of Canola Protein in Comparison With Soy Protein

Men Clinical Trial

Official title:

Comparison of the Bioavailability the of a Single Administration of Two Canola Proteins (Hydrolyzate, Isolate) and Soy Protein in Healthy Men.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01481584
• Other study ID #: LSEP H43-10
• Status: Completed
• Phase: N/A
• First received: November 24, 2011
• Last updated: March 4, 2015
• Start date: May 2010
• Est. completion date: November 2011

Study information

• Verified date: March 2015
• Source: University of Jena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: November 2011
• Est. primary completion date: July 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Men

Intervention

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.
• 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.

Locations

Country	Name	City	State
Germany	Friedrich Schiller University Jena, Department of Nutritional Physiology	Jena	Thuringia

Sponsors (1)

Lead Sponsor	Collaborator
University of Jena

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Body composition (body status)	Bioelectrical impedance analysis, body weight	At day 1	Yes
Secondary	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	Yes