Lentil protein hydrolysate for blood pressure control, vascular health, 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
This will test whether a daily lentil protein supplement helps control blood pressure and improve blood vessel function and exercise performance in healthy adults.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Nuritas Ltd Industry-sponsored |
| Locations | 1 site (Melbourne, Victoria) |
| Trial ID | NCT06894875 on ClinicalTrials.gov |
What this trial studies
Healthy men and women will take daily doses of lentil protein hydrolysate (500–2000 mg) or a placebo for four weeks while researchers monitor safety and tolerability. The trial measures clinic blood pressure, orthostatic responses, markers of vascular age and endothelial function, fatigue, quality of life, and grip strength. Exercise performance is evaluated by VO2max and substrate use during steady-state exercise, with continuous activity, sleep, and cardiac monitoring via a wearable device. Adverse events and changes from baseline will be tracked throughout the supplementation period.
Who should consider this trial
Good fit: Ideal candidates are healthy men and women aged 18–45 with BMI 18.5–<30 kg/m2 who meet ACSM physical activity guidelines, are not on medications or supplements that affect the trial, and agree to wear a monitoring device for four weeks.
Not a fit: People with known cardiovascular disease, uncontrolled hypertension, those taking blood-pressure or performance-altering medications, older adults, or those unable to wear the device are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this plant-based supplement could offer a safe, non-pharmaceutical option to modestly improve blood pressure control, vascular health, and exercise capacity in otherwise healthy adults.
How similar studies have performed: Some related bioactive protein and peptide supplements have produced modest blood pressure or endothelial function benefits in prior trials, but lentil protein hydrolysate itself is relatively novel and not yet well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Melbourne, Victoria
- Baker Heart and Diabetes Institute — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Niamh M Mohan, PhD
- Email: mohan.niamh@nuritas.com
- Phone: +353 1 430 1290
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.