Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance

NCT06894875 | Recruiting

• 1 other identifier: PEPLEN24
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Conditions

Blood Pressure; Vasodilation; Vascular Function in Healthy Volunteers; Exercise Performance; Safety and Tolerability in Healthy Volunteers; Exercise

Keywords

Exercise performance; Vascular function; blood pressure control; Lentil protein hydrolysate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording

  Day 1 to Day 28

• Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording

  Day 1

• Safety via electrolytes and liver function tests

  Day 1 to Day 28

• Arterial stiffness

  Day 1 to Day 28

• Endothelial function

  Day 1 to Day 28

Other Outcomes (2)

• Habitual physical activity via wearable device

  Day 1 to Day 28

• Sleep biometrics via wearable device

  Day 1 to Day 28

Study Arms (4)

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

Interventions

Placebo MCC micro-crystalline cellulose DIETARY_SUPPLEMENT

Placebo MCC micro-crystalline cellulose

Microcrystalline Cellulose 2000mg/day

Lentil protein hydrolysate DIETARY_SUPPLEMENT

Plant protein hydrolysate

Lentil protein hydrolysate 1000 mg/day; Lentil protein hydrolysate 2000 mg/day; Lentil protein hydrolysate 500 mg/day

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuritas Ltd: lead
• Australian Catholic University: collaborator
• Baker Heart and Diabetes Institute: collaborator

Study Sites (1)

Baker Heart and Diabetes Institute

Melbourne, Victoria, 3004, Australia

RECRUITING

MeSH Terms

Conditions

Motor Activity; Aneurysm

Condition Hierarchy (Ancestors)

Behavior; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Niamh M Mohan, PhD

CONTACT

+353 1 430 1290; mohan.niamh@nuritas.com

Brian Keogh, Phd

CONTACT

+353 1 430 1290

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, double-blind, placebo-controlled, parallel dose response study conducted over 28 days

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 25, 2025
• Study Start: June 24, 2025
• Primary Completion: December 24, 2025
• Study Completion: March 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)