NCT06058403

Brief Summary

Muscle tissue consists of proteins. These proteins are built up of small building blocks: amino acids. By consuming enough protein through the diet, the body is provided with enough amino acids to facilitate muscle protein building. Providing the growing world population with sufficient animal-derived protein is a challenge. Plant proteins can be produced on a more sustainable commercial scale than conventional animal-derived proteins and therefore can contribute to feeding our future population. Canola protein is a protein that is derived from rapeseed. The composition of canola seems to be comparable to that of other high-quality animal based protein sources. However, the collection of canola protein from rapeseed occurs in a special way. These treatment processes might affect canola protein digestion. The goal of this study is to investigate the most optimal way of canola protein processing on blood plasma amino acid responses. Primary objective: To assess the impact of canola protein processing on 5h postprandial plasma total amino acid incremental area under the curve (iAUC) in vivo in healthy young females. Hypothesis: it is hypothesized that the ingestion of 20g processed canola will result in greater 5h postprandial plasma total amino acid iAUC in vivo in healthy young females, when compared to the ingestion of 20g native canola protein isolate.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2023

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

September 5, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 28, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

October 3, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2024

Completed
Last Updated

March 30, 2026

Status Verified

October 1, 2023

Enrollment Period

8 months

First QC Date

September 5, 2023

Last Update Submit

March 25, 2026

Conditions

Keywords

Dietary proteinPlant proteinProtein processingProtein digestion

Outcome Measures

Primary Outcomes (1)

  • Total amino acid availability

    The total amino acid availability is expressed as the incremental area under the curve (iAUC)

    0 - 5 hours after drink ingestion

Secondary Outcomes (7)

  • Postprandial plasma total amino acid concentrations

    0 - 5 hours after drink ingestion

  • Postprandial plasma individual amino acid concentrations

    0 - 5 hours after drink ingestion

  • Peak plasma amino acid concentrations

    0 - 5 hours after drink ingestion

  • Time to peak plasma amino acid concentrations

    0 - 5 hours after drink ingestion

  • iAUC essential amino acids concentrations

    0 - 5 hours after drink ingestion

  • +2 more secondary outcomes

Other Outcomes (12)

  • Age in years

    Baseline at screening

  • Bodymass in kg

    Baseline at screening

  • Height in m

    Baseline at screening

  • +9 more other outcomes

Study Arms (4)

Native canola protein

EXPERIMENTAL

20g of canola protein

Dietary Supplement: 20g native canola protein drink ingestion

Processed canola protein #1

EXPERIMENTAL

20g of processed canola #1

Dietary Supplement: 20g processed canola protein #1 drink ingestion

Processed canola protein #2

EXPERIMENTAL

20g of processed canola #2

Dietary Supplement: 20g processed canola protein #2 drink ingestion

Whey protein

ACTIVE COMPARATOR

20g of whey protein

Dietary Supplement: 20g whey protein drink ingestion

Interventions

Ingestion of a 300 mL drink containing 20g whey protein

Also known as: Supplement
Whey protein

Ingestion of a 300 mL drink containing 20g native canola protein

Also known as: Supplement
Native canola protein

Ingestion of a 300 mL drink containing 20g processed canola protein #1

Also known as: Supplement
Processed canola protein #1

Ingestion of a 300 mL drink containing 20g processed canola protein #2

Also known as: Supplement
Processed canola protein #2

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female sex
  • Aged between 18 and 35 y inclusive
  • BMI between 18.5 and 30 kg/m2

You may not qualify if:

  • Intolerant to milk lactose
  • Allergic to milk protein / products
  • Mustard allergy
  • Vegan lifestyle
  • Participating in a structured (progressive) exercise program
  • Smoking regularly
  • Diagnosed GI tract disorders or diseases
  • Diagnosed musculoskeletal disorders
  • Diagnosed metabolic disorders (e.g., diabetes)
  • Hypertension (blood pressure above 140/90 mmHg)
  • Donated blood 2 months prior to test day
  • Pregnant
  • Using third generation oral contraceptives
  • Use of any medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatories).
  • Chronic use of gastric acid suppressing medication as this impairs protein digestion (i.e., proton pump inhibitors, H2-antagonists)
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University Medical Centre+

Maastricht, Limburg, 6229ER, Netherlands

Location

Related Publications (1)

  • Boot N, Hermans WJH, Warnke I, Overman A, van Kranenburg JMX, Senden JM, Verdijk LB, van Loon LJC. Evaluation of processing of canola protein isolate on postprandial plasma amino acid profiles in healthy, young females. Amino Acids. 2025 Oct 17;57(1):50. doi: 10.1007/s00726-025-03482-1.

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Luc van Loon, PhD

    Maastricht University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Randomized, controlled, double-blind, cross-over intervention trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2023

First Posted

September 28, 2023

Study Start

October 3, 2023

Primary Completion

May 27, 2024

Study Completion

May 27, 2024

Last Updated

March 30, 2026

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations