Status:
RECRUITING
Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance
Lead Sponsor:
Nuritas Ltd
Collaborating Sponsors:
Australian Catholic University
Baker Heart and Diabetes Institute
Conditions:
Exercise
Blood Pressure
Eligibility:
All Genders
18-45 years
Phase:
NA
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 exerci...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 24 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06894875
Start Date
June 24 2025
End Date
March 30 2026
Last Update
December 16 2025
Active Locations (1)
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1
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004