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
Eligibility
Sex
ALL
Min age
18 Years
Max age
45 Years
Healthy volunteers
Accepted
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.
Primary outcome measure(s)
Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting — Day 1 to Day 28 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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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