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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06894875
Registration number
NCT06894875
Ethics application status
Date submitted
10/03/2025
Date registered
25/03/2025
Date last updated
22/05/2025
Titles & IDs
Public title
Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance
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Scientific title
Examining the Safety and Tolerability of Lentil Protein Hydrolysate in Healthy Males and Females Whilst Exploring the Effects of a Dose Range on Blood Pressure Control and Vascular Function and Exercise Performance
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Secondary ID [1]
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PEPLEN24
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Exercise
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Blood Pressure
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Vasodilation
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Vascular Function in Healthy Volunteers
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Exercise Performance
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Safety and Tolerability in Healthy Volunteers
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - Lentil protein hydrolysate
Treatment: Other - Placebo MCC micro-crystalline cellulose
Experimental: Lentil protein hydrolysate 500 mg/day -
Experimental: Lentil protein hydrolysate 1000 mg/day -
Experimental: Lentil protein hydrolysate 2000 mg/day -
Placebo comparator: Microcrystalline Cellulose 2000mg/day -
Treatment: Other: Lentil protein hydrolysate
Plant protein hydrolysate
Treatment: Other: Placebo MCC micro-crystalline cellulose
Placebo MCC micro-crystalline cellulose
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Intervention code [1]
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Treatment: Other
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting
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Assessment method [1]
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Change from baseline to the end of the study period in safety via adverse event frequency and severity between placebo and a dose range of Lentil protein hydrolysate
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Timepoint [1]
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Day 1 to Day 28
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Secondary outcome [1]
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Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
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Assessment method [1]
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Elevation in resting systolic or diastolic blood pressure \>10mm Hg between baseline and after supplementation with lentil protein hydrolysate or placebo.
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Timepoint [1]
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Day 1 to Day 28
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Secondary outcome [2]
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Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
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Assessment method [2]
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Decrease in systolic (\>20mmHg) or diastolic (\>10mmHg) blood pressure upon standing after acute supplementation with lentil protein hydrolysate or placebo.
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Timepoint [2]
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Day 1
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Secondary outcome [3]
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Safety via electrolytes and liver function tests
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Assessment method [3]
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Change from baseline to the end of the study period in safety determined by combining results of a full blood test investigating concentration (cells/L) and quantity of red blood cells, white blood cells and platelets, electrolytes (mmol/L) and concentrations of liver function markers (U/L); Albumin, Bilirubin, Alanine aminotransferase (ALT), Aspartate amino transferase (AST), Gamma-glutamyl transferase (GGT) and Alkaline phosphatase (ALP)
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Timepoint [3]
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Day 1 to Day 28
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Secondary outcome [4]
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Arterial stiffness
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Assessment method [4]
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Change from baseline to the end of the study period in central arterial stiffness, measured via aortic pulse-wave velocity
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Timepoint [4]
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Day 1 to Day 28
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Secondary outcome [5]
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Endothelial function
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Assessment method [5]
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Change from baseline to the end of the study period in endothelium-dependent vascular function measured by flow-mediated dilation
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Timepoint [5]
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Day 1 to Day 28
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Secondary outcome [6]
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Substrate utilisation during sub-maximal, steady-state exercise
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Assessment method [6]
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Change from baseline to the end of the study period in the rate of oxygen consumption and the oxidative rate of fat and carbohydrates during steady-state exercise
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Timepoint [6]
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Day 1 to Day 28
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Secondary outcome [7]
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Cardiorespiratory fitness (VO2max)
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Assessment method [7]
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Change from baseline to the end of the study period in cardiorespiratory fitness measured during a cardiopulmonary exercise test
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Timepoint [7]
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Day 1 to Day 28
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Secondary outcome [8]
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Blood pressure response to exercise
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Assessment method [8]
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Change from baseline to the end of the study period in blood pressure response to cardiopulmonary exercise test
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Timepoint [8]
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Day 1 to Day 28
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Secondary outcome [9]
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Quality of life via 12-item Short-Form Health Survey version 2
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Assessment method [9]
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Change from baseline to the end of the study period in general health via 12-item Short-Form Health Survey version 2
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Timepoint [9]
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Day 1 to Day 28
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Secondary outcome [10]
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Fatigue symptoms via Multidimensional Fatigue Inventory
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Assessment method [10]
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Change from baseline to the end of the study period in fatigue symptoms measured via Multidimensional Fatigue Inventory where scores range from 1 (no fatigue) to 50 (severe fatigue)
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Timepoint [10]
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Day 1 to Day 28
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Secondary outcome [11]
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Grip Strength
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Assessment method [11]
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Change from baseline to the end of the study period in hand grip strength measured via a hand-held dynamometer
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Timepoint [11]
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Day 1 to Day 28
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Secondary outcome [12]
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Markers associated with inflammation via blood test
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Assessment method [12]
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Change from baseline to the end of the study period in inflammatory Markers such as CRP
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Timepoint [12]
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Day 1 to Day 28
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Eligibility
Key inclusion criteria
* Willing to provide written and dated informed consent to participate in the study.
* Willing and able to comply with the protocol.
* Are not on any medication, or supplements which would impact the trial in the opinions of the investigator or Sponsor.
* Male or female between 18 and 45 years of age (18.5 kg/m2 = BMI < 30 kg/m2).
* Comply with ACSM guidelines for physical activity.
* Have not participated in a clinical trial within the past month and agree to not participate in another clinical trial during the study period.
* Agree to not significantly alter diet or exercise routine during the trial period.
* Willing to wear a wearable device continuously for the duration of the study
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Subjects having a known allergy or hypersensitivity to any of the ingredients in the investigational products.
* Subjects with a history of alcohol and/or other drug abuse in the past year.
* Has performed strenuous exercise (rating of perceived exertion = 13) = 48 hours before laboratory visit (Borg, 1982).
* Consuming >14 alcoholic drinks per week or > 2 drinks/day in the 48 hours preceding a clinic visit.
* Active smokers, nicotine use or vaping
* Subjects suffering from a sleep disorder and/or who have a known history of (or was being treated for) clinical depression, eating disorder(s) or any other psychiatric condition(s) that might put the subject at risk and/or confounded the results of the study.
* Subjects with a history of being diagnosed with phenylketonuria or another disease affecting amino acid metabolism (i.e., maple syrup urine disease, etc.).
* Subjects with an elevated resting heart rate (>100 bpm) or blood pressure (systolic BP >140 mmHg or diastolic BP >90 mmHg).
* Pregnant or lactating women
* Presentation of orthostatic hypotension during the screening and familiarisation study visit
* Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion.
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
24/06/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/12/2025
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Actual
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Sample size
Target
48
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Baker Heart and Diabetes Institute - Melbourne
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Recruitment postcode(s) [1]
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3004 - Melbourne
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Nuritas Ltd
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Australian Catholic University
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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Baker Heart and Diabetes Institute
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
Brief summary
Examining the safety and tolerability of Lentil Protein Hydrolysate in healthy males and females whilst exploring the effects of a dose range on blood pressure control and vascular function and exercise performance
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Trial website
https://clinicaltrials.gov/study/NCT06894875
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Niamh M Mohan, PhD
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Address
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Country
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Phone
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+353 1 430 1290
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT06894875
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