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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
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
Secondary ID [1] 0 0
PEPLEN24
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise 0 0
Blood Pressure 0 0
Vasodilation 0 0
Vascular Function in Healthy Volunteers 0 0
Exercise Performance 0 0
Safety and Tolerability in Healthy Volunteers 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting
Timepoint [1] 0 0
Day 1 to Day 28
Secondary outcome [1] 0 0
Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
Timepoint [1] 0 0
Day 1 to Day 28
Secondary outcome [2] 0 0
Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
Timepoint [2] 0 0
Day 1
Secondary outcome [3] 0 0
Safety via electrolytes and liver function tests
Timepoint [3] 0 0
Day 1 to Day 28
Secondary outcome [4] 0 0
Arterial stiffness
Timepoint [4] 0 0
Day 1 to Day 28
Secondary outcome [5] 0 0
Endothelial function
Timepoint [5] 0 0
Day 1 to Day 28
Secondary outcome [6] 0 0
Substrate utilisation during sub-maximal, steady-state exercise
Timepoint [6] 0 0
Day 1 to Day 28
Secondary outcome [7] 0 0
Cardiorespiratory fitness (VO2max)
Timepoint [7] 0 0
Day 1 to Day 28
Secondary outcome [8] 0 0
Blood pressure response to exercise
Timepoint [8] 0 0
Day 1 to Day 28
Secondary outcome [9] 0 0
Quality of life via 12-item Short-Form Health Survey version 2
Timepoint [9] 0 0
Day 1 to Day 28
Secondary outcome [10] 0 0
Fatigue symptoms via Multidimensional Fatigue Inventory
Timepoint [10] 0 0
Day 1 to Day 28
Secondary outcome [11] 0 0
Grip Strength
Timepoint [11] 0 0
Day 1 to Day 28
Secondary outcome [12] 0 0
Markers associated with inflammation via blood test
Timepoint [12] 0 0
Day 1 to Day 28

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
24/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/12/2025
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Baker Heart and Diabetes Institute - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Nuritas Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Australian Catholic University
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Baker Heart and Diabetes Institute
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Niamh M Mohan, PhD
Address 0 0
Country 0 0
Phone 0 0
+353 1 430 1290
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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