- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06058403
Impact of Canola Protein Processing on Plasma Amino Acid Responses (CANOLAA)
The Impact of Canola Protein Processing on Postprandial Plasma Amino Acid Responses in Vivo in Young Females
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.
Study Overview
Status
Conditions
Detailed Description
To assess whether volunteers are eligible to participate in this study, the investigator will invite them to the University for a screening. At the start of the screening session, the entire experimental trial will be explained, and any potential questions will be answered. Thereafter, the volunteers are asked to read, fill out, and sign the informed consent form. After signing the informed consent form, the participant's eligibility will be assessed based on the in- and exclusion criteria. To further asses their eligibility, participants will be asked to fill out a medical questionnaire to assess their general health, use of medication, habitual food intake, and physical activity. Next, blood pressure will be assessed. Body mass (with accuracy of 0.1 kg) and height (with accuracy of 0.01 m) will be determined. The screening sessions will take place in the morning and participants are instructed to not have any breakfast in the morning in order to avoid perturbations in body weight and possibly in the DEXA scan. In the event of an unexpected medical finding during the screening, subjects will always be notified. If a subject does not want to receive this notification, she cannot participate in the study. When the screening is successfully performed, the test days will be scheduled. Protein and amino acid metabolism in women can be influenced by the menstrual cycle. Therefore, the experimental test days will be standardized in a specific period of the menstrual cycle. The test days will be planned in the first 10 days after the start of the menses (day 1 of the follicular phase), when hormones levels (i.e., estrogen) are low. In practice, this means that the test days will be planned based on the subjects' menstrual cycle. Therefore, 2 test days can be performed within 1 menstrual cycle (allowing 2 days between test days for standardization) and further test days will be planned approximately 28 days thereafter. This allows the investigators to finish testing for a single participant within a relatively short time frame while still taking the menstrual cycle and accompanying hormonal influences into consideration. A similar approach was used in our lab in previous studies that included young healthy women (METC17-3-047 & METC19-087). Throughout the study period, participants will also undergo a fasted Dual Energy X-ray Absorptiometry (DEXA) scan to assess body composition. A DEXA scan is a simple, non-invasive procedure. At the beginning of the procedure, subjects will be asked to lie down on a scanning table wearing underwear and they need to remain motionless during the measurements. As the scanner moves, a dual energy beam passes through the targeted skeletal muscle section and is measured by a detector. This procedure takes approximately 3 minutes. The DEXA-scan provides valuable insight in participants' body composition, with minimal radiation burden.
When the screening is successfully performed, the test day will be scheduled. In order to prevent major impact from the menstrual cycle on the measurements of protein metabolism, the test day will be scheduled to take place in the first 10 days of the follicular phase.
Each subject will participate in 4 experimental test days lasting ~5h. Subjects will be instructed to arrive at the university at 8:45 AM in an overnight fasted and rested state, meaning that participants are not allowed to eat and drink (except for water) from 22:00 the night prior to the experimental trial. They will be instructed to come to the university by car or public transportation. After the subjects arrive at the University, subjects will rest in a seated position and a Teflon catheter will be inserted in a heated dorsal hand vein and placed in a hot-box (60°C) for arterialized blood sampling. A baseline blood sample (Serum + plasma = 20 mL) will be collected at t=0 min to determine the amino acid concentrations prior to the intervention.
Then, subjects will ingest the assigned drink (20g native canola protein, 20g processed canola protein #1, 20g processed canola protein #2, or 20g whey protein). Subjects will be instructed to consume the drink within ~5 min. Upon drink ingestion, the stopwatch will be started (t= 0 min), and arterialized blood samples (10mL) will be collected at t = 15, 30, 45, 60, 90, 120, 180, 240, and 300 min. During the entire experimental test day, the hand with the dorsal hand catheter will be pre-heated for 10 minutes prior to every blood draw in a hot box at 60°C to increase blood flow. This makes it easier to collect blood and minimizes nutrient exchange from blood into other tissues. Therefore, it allows the investigators to collect nutrient-rich (arterialized) blood from a vein.
In total 10 times blood samples will be taken during the test day, the first sample that will be collected will be 20mL and subsequent samples will be 10mL, making a total of 110mL.
Additionally, gastro-intestinal (GI) symptoms will be assessed at t = 0, 30, and 180 minutes and palatability at t = 15 min by questionnaires.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Luc van Loon, PhD
- Phone Number: 0031433881397
- Email: l.vanloon@maastrichtuniversity.nl
Study Contact Backup
- Name: Wesley Hermans, MSc
- Phone Number: 0031433881810
- Email: w.hermans@maastrichtuniversity.nl
Study Locations
-
-
Limburg
-
Maastricht, Limburg, Netherlands, 6229ER
- Recruiting
- Maastricht University Medical Centre+
-
Contact:
- Luc van Loon, PhD
- Phone Number: 0031433881397
- Email: l.vanloon@maastrichtuniversity.nl
-
Contact:
- Wesley Hermans, MSc
- Phone Number: 0031433881810
- Email: w.hermans@maastrichtuniversity.nl
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female sex
- Aged between 18 and 35 y inclusive
- BMI between 18.5 and 30 kg/m2
Exclusion Criteria:
- 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)
- People with Phenylketonuria
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Whey protein
20g of whey protein
|
Ingestion of a 300 mL drink containing 20g whey protein
Other Names:
|
Experimental: Native canola protein
20g of canola protein
|
Ingestion of a 300 mL drink containing 20g native canola protein
Other Names:
|
Experimental: Processed canola protein #1
20g of processed canola #1
|
Ingestion of a 300 mL drink containing 20g processed canola protein #1
Other Names:
|
Experimental: Processed canola protein #2
20g of processed canola #2
|
Ingestion of a 300 mL drink containing 20g processed canola protein #2
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total amino acid availability
Time Frame: 0 - 5 hours after drink ingestion
|
The total amino acid availability is expressed as the incremental area under the curve (iAUC)
|
0 - 5 hours after drink ingestion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postprandial plasma total amino acid concentrations
Time Frame: 0 - 5 hours after drink ingestion
|
The total plasma amino acid concentrations from the sum of the individual amino acids
|
0 - 5 hours after drink ingestion
|
Postprandial plasma individual amino acid concentrations
Time Frame: 0 - 5 hours after drink ingestion
|
The plasma amino acid concentrations of the individual amino acids
|
0 - 5 hours after drink ingestion
|
Peak plasma amino acid concentrations
Time Frame: 0 - 5 hours after drink ingestion
|
The maximal plasma amino acid concentrations
|
0 - 5 hours after drink ingestion
|
Time to peak plasma amino acid concentrations
Time Frame: 0 - 5 hours after drink ingestion
|
The time to reach maximal plasma amino acid concentrations
|
0 - 5 hours after drink ingestion
|
iAUC essential amino acids concentrations
Time Frame: 0 - 5 hours after drink ingestion
|
Essential amino acid availability expressed as incremental area under the curve (iAUC)
|
0 - 5 hours after drink ingestion
|
iAUC non-essential amino acid concentrations
Time Frame: 0 - 5 hours after drink ingestion
|
non-essential amino acid availability expressed as incremental area under the curve (iAUC)
|
0 - 5 hours after drink ingestion
|
Plasma insulin concentrations
Time Frame: 0 - 5 hours after drink ingestion
|
Postprandial plasma insulin concentrations
|
0 - 5 hours after drink ingestion
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Age in years
Time Frame: Baseline at screening
|
Age in years reported by participants
|
Baseline at screening
|
Bodymass in kg
Time Frame: Baseline at screening
|
Scale
|
Baseline at screening
|
Height in m
Time Frame: Baseline at screening
|
Statiometer
|
Baseline at screening
|
BMI in kg/m^2
Time Frame: Baseline at screening
|
calculated from height and body mass
|
Baseline at screening
|
Whole body lean mass in kilograms
Time Frame: Up to 3 months after inclusion
|
DEXA
|
Up to 3 months after inclusion
|
Appendicular lean mass
Time Frame: Up to 3 months after inclusion
|
DEXA
|
Up to 3 months after inclusion
|
Bodyfat%
Time Frame: Up to 3 months after inclusion
|
DEXA
|
Up to 3 months after inclusion
|
Dietary energy intake
Time Frame: Two days prior to first experimental trial day
|
Assessed by written dietary intake records
|
Two days prior to first experimental trial day
|
Dietary protein intake
Time Frame: Two days prior to first experimental trial day
|
Assessed by written dietary intake records
|
Two days prior to first experimental trial day
|
Dietary fat intake
Time Frame: Two days prior to first experimental trial day
|
Assessed by written dietary intake records
|
Two days prior to first experimental trial day
|
Dietary carbohydrate intake
Time Frame: Two days prior to first experimental trial day
|
Assessed by written dietary intake records
|
Two days prior to first experimental trial day
|
Drink palatability
Time Frame: On experimental trial day directly after drink ingestion
|
Assessed by visual analogue scale after drink ingestion.
Higher score means better taste (scoring 0-100)
|
On experimental trial day directly after drink ingestion
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Luc van Loon, PhD, Maastricht University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL83369.068.23 / METC 23-025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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