Clinical trial NCT06894875: Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Exercise
Blood Pressure
Vasodilation
Vascular Function in Healthy Volunteers
Exercise Performance
Safety and Tolerability in Healthy Volunteers
Keywords: Exercise performance
Vascular function
blood pressure control
Lentil protein hydrolysate
Lead sponsor: Nuritas Ltd
Sponsor class: INDUSTRY
Collaborators: name: Australian Catholic University
name: Baker Heart and Diabetes Institute
First posted: 2025-03-25
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, placebo-controlled, parallel dose response study conducted over 28 days
Primary purpose: OTHER

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 exercise performance

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 exercise performance. The study will be conducted in men and women over 4 weeks.

Specifically, the study has three key objectives:

1. To determine the safety and tolerability of 500 - 2000mg of a novel plant-based supplement LPH) in healthy volunteers as assessed via AE reporting, changes in clinic blood pressure and supplementation induced orthostatic hypotension during a sit-to-stand challenge.
2. To explore the effects of 4-weeks of lentil protein hydrolysate supplementation on markers of vascular age and endothelial function, fatigue, quality of life, and grip strength.
3. To explore the effects of 4-weeks of LPH supplementation on markers of exercise performance, including cardiorespiratory fitness (VO2max) and substrate utilisation during sub-maximal, steady-state exercise. This trial incorporates a wearable device to measure physical activity, cardiac health, sleep metrics and heart rate variability.

Eligibility 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.

Primary outcomes:
measure: Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting
timeFrame: Day 1 to Day 28
Secondary outcomes:
measure: Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
timeFrame: Day 1 to Day 28
measure: Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording
timeFrame: Day 1
measure: Safety via electrolytes and liver function tests
timeFrame: Day 1 to Day 28
measure: Arterial stiffness
timeFrame: Day 1 to Day 28
measure: Endothelial function
timeFrame: Day 1 to Day 28
measure: Substrate utilisation during sub-maximal, steady-state exercise
timeFrame: Day 1 to Day 28
measure: Cardiorespiratory fitness (VO2max)
timeFrame: Day 1 to Day 28
measure: Blood pressure response to exercise
timeFrame: Day 1 to Day 28
measure: Quality of life via 12-item Short-Form Health Survey version 2
timeFrame: Day 1 to Day 28
measure: Fatigue symptoms via Multidimensional Fatigue Inventory
timeFrame: Day 1 to Day 28
measure: Grip Strength
timeFrame: Day 1 to Day 28
measure: Markers associated with inflammation via blood test
timeFrame: Day 1 to Day 28
Other outcomes:
measure: Habitual physical activity via wearable device
timeFrame: Day 1 to Day 28
measure: Sleep biometrics via wearable device
timeFrame: Day 1 to Day 28
Locations:
city: Melbourne
country: Australia
facility: Baker Heart and Diabetes Institute
state: Victoria
Study officials:
References: