Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise Performance
NCT ID: NCT06894875
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
48 participants
INTERVENTIONAL
2025-06-24
2026-03-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
OTHER
TRIPLE
Study Groups
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Lentil protein hydrolysate 500 mg/day
Lentil protein hydrolysate
Plant protein hydrolysate
Lentil protein hydrolysate 1000 mg/day
Lentil protein hydrolysate
Plant protein hydrolysate
Lentil protein hydrolysate 2000 mg/day
Lentil protein hydrolysate
Plant protein hydrolysate
Microcrystalline Cellulose 2000mg/day
Placebo MCC micro-crystalline cellulose
Placebo MCC micro-crystalline cellulose
Interventions
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Lentil protein hydrolysate
Plant protein hydrolysate
Placebo MCC micro-crystalline cellulose
Placebo MCC micro-crystalline cellulose
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
45 Years
ALL
Yes
Sponsors
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Australian Catholic University
OTHER
Baker Heart and Diabetes Institute
OTHER
Nuritas Ltd
INDUSTRY
Responsible Party
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Locations
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Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Brian Keogh, Phd
Role: CONTACT
Facility Contacts
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Other Identifiers
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PEPLEN24
Identifier Type: -
Identifier Source: org_study_id