Effects of Lentil Protein Hydrolysate on Blood Pressure Control, 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

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

Study Overview

• Status: Recruiting
• Conditions: Exercise; Blood Pressure; Vasodilation; Exercise Performance; Safety and Tolerability in Healthy Volunteers; Vascular Function in Healthy Volunteers
• Intervention / Treatment: Dietary supplement: Placebo MCC micro-crystalline cellulose; Dietary supplement: Lentil protein hydrolysate

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:

1. 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.
2. 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.
3. 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 Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Keogh, Phd; Phone Number: +353 1 430 1290
• Study Contact Backup: Name: Niamh M Mohan, PhD; Phone Number: +353 1 430 1290; Email: mohan.niamh@nuritas.com

Study Locations

• Australia
  • Victoria
    • Melbourne, Victoria, Australia, 3004
      • Recruiting
      • Baker Heart and Diabetes Institute
      • Contact: Erin Howden, Phd; Phone Number: +61 3 8532 1800; Email: Erin.Howden@baker.edu.au

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lentil protein hydrolysate 500 mg/day	Dietary supplement: Lentil protein hydrolysate; Plant protein hydrolysate
Experimental: Lentil protein hydrolysate 1000 mg/day	Dietary supplement: Lentil protein hydrolysate; Plant protein hydrolysate
Experimental: Lentil protein hydrolysate 2000 mg/day	Dietary supplement: Lentil protein hydrolysate; Plant protein hydrolysate
Placebo Comparator: Microcrystalline Cellulose 2000mg/day	Dietary supplement: Placebo MCC micro-crystalline cellulose; Placebo MCC micro-crystalline cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Day 1 to Day 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	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	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	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	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	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	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	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)	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	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	Day 1 to Day 28

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	Day 1 to Day 28

Collaborators and Investigators

• Sponsor: Nuritas Ltd
• Collaborators: Australian Catholic University; Baker Heart and Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2025
• Primary Completion (Estimated): December 24, 2025
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: March 10, 2025
• First Submitted That Met QC Criteria: March 19, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 15, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Vascular function; blood pressure control; Exercise performance; Lentil protein hydrolysate
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Behavior; Aneurysm; Motor Activity
• Other Study ID Numbers: PEPLEN24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No