Lentil protein hydrolysate for blood pressure control, vascular health, and exercise performance

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.