Actively Recruiting
Examining the Safety and Tolerability of Lentil Protein Hydrolysate in Healthy Males and Females While Exploring Effects on Blood Pressure Control, Vascular Function, and Exercise Performance
Led by Nuritas Ltd · Updated on 2025-12-16
48
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
Sponsors
N
Nuritas Ltd
Lead Sponsor
A
Australian Catholic University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of a plant-based supplement called lentil protein hydrolysate (LPH) in healthy men and women aged 18 to 45. The study also explores how different doses of LPH affect blood pressure control, vascular health, and exercise performance over a 4-week period. This trial aims to understand the impact of LPH on markers of vascular age, fatigue, quality of life, grip strength, and cardiorespiratory fitness. Participants will be randomly assigned to receive one of several doses of lentil protein hydrolysate (500 mg, 1000 mg, or 2000 mg daily) or a placebo containing microcrystalline cellulose. The intervention lasts 4 weeks, during which participants will take the assigned supplement daily. The study uses a wearable device to continuously monitor physical activity, cardiac health, sleep, and heart rate variability. Throughout the 4 weeks, participants will undergo regular assessments including monitoring for adverse events, clinic blood pressure measurements, and exercise testing to measure fitness and substrate use. Safety tests such as liver function and electrolyte levels will also be conducted. Additional evaluations include arterial stiffness, endothelial function, fatigue questionnaires, quality of life surveys, grip strength tests, and inflammation markers. The total participation duration is 28 days with close monitoring of safety and tolerability.
CONDITIONS
Brief Title
Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to provide written and dated informed consent to participate in the study.
- Willing and able to comply with the protocol.
- Not taking medications or supplements that may impact the trial, as judged by the investigator or sponsor.
- Male or female between 18 and 45 years old with BMI between 18.5 and less than 30 kg/m2.
- Comply with ACSM guidelines for physical activity.
- Have not participated in another clinical trial within the past month and agree not to participate in another during this study.
- Agree not to significantly change diet or exercise routine during the trial.
- Willing to wear a wearable device continuously during the study.
You will not qualify if you...
- Known allergy or sensitivity to any ingredients in the investigational products.
- History of alcohol or drug abuse in the past year.
- Performed strenuous exercise (perceived exertion ≥13) within 48 hours before a lab visit.
- Consuming more than 14 alcoholic drinks per week or more than 2 drinks per day in the 48 hours before clinic visits.
- Active smokers, nicotine users, or vaping.
- Suffering from sleep disorders, clinical depression, eating disorders, or other psychiatric conditions that might risk safety or affect study results.
- Diagnosed with phenylketonuria or diseases affecting amino acid metabolism.
- Elevated resting heart rate over 100 bpm or blood pressure over 140/90 mmHg.
- Pregnant or breastfeeding women.
- Presentation of orthostatic hypotension during screening.
- Any other condition judged by the investigator to make participation unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants take a lentil protein hydrolysate or placebo daily for 4 weeks to evaluate safety, tolerability, and effects on blood pressure, vascular function, and exercise performance.
Baseline visit and multiple follow-up visits during supplementation
Trial Site Locations
Total: 1 location
1
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia, 3004
Actively Recruiting
Research Team
N
Niamh M Mohan, PhD
B
Brian Keogh, Phd
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
4
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