NCT06894875

Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Nuritas Ltd · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Exercise
• Blood Pressure
• Vasodilation
• Vascular Function in Healthy Volunteers
• Exercise Performance
• Safety and Tolerability in Healthy Volunteers

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lentil protein hydrolysate	Plant protein hydrolysate
DIETARY_SUPPLEMENT	Placebo MCC micro-crystalline cellulose	Placebo MCC micro-crystalline cellulose

Timeline

• Start date: 2025-06-24
• Primary completion: 2025-12-24
• Completion: 2026-03-30
• First posted: 2025-03-25
• Last updated: 2025-12-16

Locations

1 site across 1 country: Australia