An interventional study of Lentil protein hydrolysate and Placebo MCC micro-crystalline cellulose in Exercise, Blood Pressure and Vasodilation, sponsored by Nuritas Ltd. Recruiting at 1 site in Australia. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.
Sponsored by Nuritas Ltd · Not applicable, Interventional, and Other
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
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:
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This study's planned enrollment of 48 is below the median of 60 across 8,388 interventional studies indexed under Motor Activity.
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Compared within Motor Activity, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Lentil protein hydrolysate
Dietary Supplement: Lentil protein hydrolysate
Dietary Supplement: Lentil protein hydrolysate
Dietary Supplement: Placebo MCC micro-crystalline cellulose
Plant protein hydrolysate
Placebo MCC micro-crystalline cellulose
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
Time frame: Day 1 to Day 28
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.
Time frame: 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.
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: Day 1 to Day 28
Habitual physical activity via wearable device
Change from baseline to the end of the study period in habitual physical activity measured via a 3D accelerometer
Time frame: Day 1 to Day 28
Sleep biometrics via wearable device
Change from baseline to the end of the study period in biometric measures of sleep quality including heart rate (BPM), heart rate variability (RMSSD) and phases of sleep (mins in REM, deep and light) which will be combined to assess overall impact on sleep score (0-100) and readiness score (0-100).
Time frame: Day 1 to Day 28
Plan to share: No
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