NCT01481584

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 24, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 29, 2011

Completed
Last Updated

March 5, 2015

Status Verified

March 1, 2015

Enrollment Period

2 months

First QC Date

November 24, 2011

Last Update Submit

March 4, 2015

Conditions

Men

Keywords

Dietary proteinCanola proteinProtein metabolismProtein-enriched drinksNitrogen balance

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Body composition (body status)

    At day 1

  • Nitrogen balance

    After day 0 and 1

Study Arms (4)

Canola protein

EXPERIMENTAL

Canola protein (Brassica juncea; incorporated in a drink)

Dietary Supplement: Protein drink - protein isolateDietary Supplement: Protein drink - protein hydrolyzate

Reference protein

ACTIVE COMPARATOR

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

Dietary Supplement: Protein drink - protein isolateDietary Supplement: Protein drink - protein hydrolyzate

Wash out

NO INTERVENTION

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

Run-in

NO INTERVENTION

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

Interventions

Protein drink - protein isolateDIETARY_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.

Also known as: CPI
Canola proteinReference protein
Protein drink - protein hydrolyzateDIETARY_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.

Also known as: CPH
Canola proteinReference protein

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Intake of pharmaceuticals
  • Allergy against canola protein or soy protein
  • Kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich Schiller University Jena, Department of Nutritional Physiology

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23260747DERIVED

MeSH Terms

Conditions

Multiple Endocrine Neoplasia Type 1

Interventions

cyclopropapyrroloindole

Condition Hierarchy (Ancestors)

Multiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System Diseases

Study Officials

  • Gerhard Jahreis, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

November 24, 2011

First Posted

November 29, 2011

Study Start

May 1, 2010

Primary Completion

July 1, 2010

Study Completion

November 1, 2011

Last Updated

March 5, 2015

Record last verified: 2015-03

Locations

DE(1)