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
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).
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.
Parallel
Lentil protein hydrolysate
Dietary supplementPlant protein hydrolysate
Placebo MCC micro-crystalline cellulose
Dietary supplementPlacebo MCC micro-crystalline cellulose
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
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.
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.
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)
Arterial stiffness
Change from baseline to the end of the study period in central arterial stiffness, measured via aortic pulse-wave velocity
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
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).
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Nuritas Ltd
Lead sponsor
Australian Catholic University
Collaborator
Baker Heart and Diabetes Institute
Collaborator
