ExerciseNCT06894875
Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance
A study testing Lentil protein hydrolysate in people with Exercise and Blood Pressure, run by Nuritas Ltd at 1 site in Australia.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise, Blood Pressure, Vasodilation
- What is being tested?
- Lentil protein hydrolysate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- 24 Jun 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brian Keogh, Phd contact
Australia1 site, 1 recruiting
- Recruiting
Baker Heart and Diabetes Institute
Melbourne, Victoria, 3004
Erin Howden, Phd, +61 3 8532 1800, Erin.Howden@baker.edu.au
About this study
Official 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
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
Read the detailed description
The aim of this trial is to evaluate the safety and tolerability of a lentil protein hydrolysate (LPH) in healthy participants while exploring effects on blood pressure control, vascular function and exercise performance. The study will be conducted in men and women over 4 weeks.
Specifically, the study has three key objectives:
- To determine the safety and tolerability of 500 - 2000mg of a novel plant-based supplement LPH) in healthy volunteers as assessed via AE reporting, changes in clinic blood pressure and supplementation induced orthostatic hypotension during a sit-to-stand challenge.
- To explore the effects of 4-weeks of lentil protein hydrolysate supplementation on markers of vascular age and endothelial function, fatigue, quality of life, and grip strength.
- To explore the effects of 4-weeks of LPH supplementation on markers of exercise performance, including cardiorespiratory fitness (VO2max) and substrate utilisation during sub-maximal, steady-state exercise. This trial incorporates a wearable device to measure physical activity, cardiac health, sleep metrics and heart rate variability.
- Conditions
- Exercise, Blood Pressure, Vasodilation, Vascular Function in Healthy Volunteers, Exercise Performance, Safety and Tolerability in Healthy Volunteers
- Being tested
- Lentil protein hydrolysate, Placebo MCC micro-crystalline cellulose
- Keywords
- Exercise performance, Vascular function, blood pressure control, Lentil protein hydrolysate
- Medical subject headings
- Motor Activity, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lentil protein hydrolysateDietary supplement
Plant protein hydrolysate
Placebo MCC micro-crystalline celluloseDietary supplement
Placebo MCC micro-crystalline cellulose
| Study group | Role | What they receive |
|---|---|---|
| Lentil protein hydrolysate 500 mg/day | Experimental | Not described Receives: Dietary Supplement: Lentil protein hydrolysate |
| Lentil protein hydrolysate 1000 mg/day | Experimental | Not described Receives: Dietary Supplement: Lentil protein hydrolysate |
| Lentil protein hydrolysate 2000 mg/day | Experimental | Not described Receives: Dietary Supplement: Lentil protein hydrolysate |
| Microcrystalline Cellulose 2000mg/day | Placebo comparator | Not described Receives: Dietary Supplement: Placebo MCC micro-crystalline cellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting
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
Measured: Day 1 to Day 28
Secondary outcomes (12)
Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
Elevation in resting systolic or diastolic blood pressure >10mm Hg between baseline and after supplementation with lentil protein hydrolysate or placebo.
Measured: Day 1 to Day 28
Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
Decrease in systolic (>20mmHg) or diastolic (>10mmHg) blood pressure upon standing after acute supplementation with lentil protein hydrolysate or placebo.
Measured: Day 1
Safety via electrolytes and liver function tests
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)
Measured: Day 1 to Day 28
Arterial stiffness
Change from baseline to the end of the study period in central arterial stiffness, measured via aortic pulse-wave velocity
Measured: Day 1 to Day 28
Endothelial function
Change from baseline to the end of the study period in endothelium-dependent vascular function measured by flow-mediated dilation
Measured: Day 1 to Day 28
Substrate utilisation during sub-maximal, steady-state exercise
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
Measured: Day 1 to Day 28
Cardiorespiratory fitness (VO2max)
Change from baseline to the end of the study period in cardiorespiratory fitness measured during a cardiopulmonary exercise test
Measured: Day 1 to Day 28
Blood pressure response to exercise
Change from baseline to the end of the study period in blood pressure response to cardiopulmonary exercise test
Measured: Day 1 to Day 28
Quality of life via 12-item Short-Form Health Survey version 2
Change from baseline to the end of the study period in general health via 12-item Short-Form Health Survey version 2
Measured: Day 1 to Day 28
Fatigue symptoms via Multidimensional Fatigue Inventory
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)
Measured: Day 1 to Day 28
Grip Strength
Change from baseline to the end of the study period in hand grip strength measured via a hand-held dynamometer
Measured: Day 1 to Day 28
Markers associated with inflammation via blood test
Change from baseline to the end of the study period in inflammatory Markers such as CRP
Measured: Day 1 to Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study start24 Jun 2025
- Primary completion24 Dec 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel dose response study conducted over 28 days
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuritas Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Australian Catholic University, Baker Heart and Diabetes Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894875
- Sponsor's protocol ID
- PEPLEN24
- Status last verified
- Dec 2025
- First submitted
- 10 Mar 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06894875
- Acronym / sponsor ID
- PEPLEN24
- Conditions
- Exercise, Blood Pressure, Vasodilation, Vascular Function in Healthy Volunteers, Exercise Performance, Safety and Tolerability in Healthy Volunteers
- Keywords
- Exercise performance, Vascular function, blood pressure control, Lentil protein hydrolysate
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Nuritas LtdIndustry (pharma, biotech, devices)
- Collaborators
- Australian Catholic University, Baker Heart and Diabetes Institute
- Study start
- 24 Jun 2025 (actual)
- Primary completion
- 24 Dec 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 25 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The aim of this trial is to evaluate the safety and tolerability of a lentil protein hydrolysate (LPH) in healthy participants while exploring effects on blood pressure control, vascular function and exercise performance. The study will be conducted in men and women over 4 weeks.
Specifically, the study has three key objectives:
- To determine the safety and tolerability of 500 - 2000mg of a novel plant-based supplement LPH) in healthy volunteers as assessed via AE reporting, changes in clinic blood pressure and supplementation induced orthostatic hypotension during a sit-to-stand challenge.
- To explore the effects of 4-weeks of lentil protein hydrolysate supplementation on markers of vascular age and endothelial function, fatigue, quality of life, and grip strength.
- To explore the effects of 4-weeks of LPH supplementation on markers of exercise performance, including cardiorespiratory fitness (VO2max) and substrate utilisation during sub-maximal, steady-state exercise. This trial incorporates a wearable device to measure physical activity, cardiac health, sleep metrics and heart rate variability.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Randomized, double-blind, placebo-controlled, parallel dose response study conducted over 28 days
| Arm | Type | Receives |
|---|---|---|
| Lentil protein hydrolysate 500 mg/day | Experimental | Dietary Supplement: Lentil protein hydrolysate |
| Lentil protein hydrolysate 1000 mg/day | Experimental | Dietary Supplement: Lentil protein hydrolysate |
| Lentil protein hydrolysate 2000 mg/day | Experimental | Dietary Supplement: Lentil protein hydrolysate |
| Microcrystalline Cellulose 2000mg/day | Placebo comparator | Dietary Supplement: Placebo MCC micro-crystalline cellulose |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lentil protein hydrolysatePlant protein hydrolysate | Dietary supplement | Lentil protein hydrolysate 1000 mg/day, Lentil protein hydrolysate 2000 mg/day, Lentil protein hydrolysate 500 mg/day |
| Placebo MCC micro-crystalline cellulosePlacebo MCC micro-crystalline cellulose | Dietary supplement | Microcrystalline Cellulose 2000mg/day |
Primary outcome
Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting
Time frame: Day 1 to Day 28
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
12 secondary outcomes
Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
Time frame: Day 1 to Day 28
Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
Time frame: Day 1
Safety via electrolytes and liver function tests
Time frame: Day 1 to Day 28
Arterial stiffness
Time frame: Day 1 to Day 28
Endothelial function
Time frame: Day 1 to Day 28
Substrate utilisation during sub-maximal, steady-state exercise
Time frame: Day 1 to Day 28
Cardiorespiratory fitness (VO2max)
Time frame: Day 1 to Day 28
Blood pressure response to exercise
Time frame: Day 1 to Day 28
Quality of life via 12-item Short-Form Health Survey version 2
Time frame: Day 1 to Day 28
Fatigue symptoms via Multidimensional Fatigue Inventory
Time frame: Day 1 to Day 28
Grip Strength
Time frame: Day 1 to Day 28
Markers associated with inflammation via blood test
Time frame: Day 1 to Day 28
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brian Keogh, Phd contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lentil protein hydrolysate in people with Exercise and Blood Pressure, run by Nuritas Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Niamh M Mohan, PhD (+353 1 430 1290, mohan.niamh@nuritas.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting (time frame: Day 1 to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.