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

Nuritas

Status: Not yet enrolling

Conditions: Vascular Function in Healthy Volunteers; Safety and Tolerability in Healthy Volunteers; Exercise Performance; Vasodilation; Blood Pressure; Exercise

Treatments: Dietary Supplement: Placebo MCC micro-crystalline cellulose; Dietary Supplement: Lentil protein hydrolysate

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06894875

PEPLEN24

Details and patient eligibility

About

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

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

Lentil protein hydrolysate 500 mg/day

Experimental group

Treatment:

Dietary Supplement: Lentil protein hydrolysate

Lentil protein hydrolysate 1000 mg/day

Experimental group

Treatment:

Dietary Supplement: Lentil protein hydrolysate

Lentil protein hydrolysate 2000 mg/day

Experimental group

Treatment:

Dietary Supplement: Lentil protein hydrolysate

Microcrystalline Cellulose 2000mg/day

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo MCC micro-crystalline cellulose