Exercise, Blood Pressure, Vasodilation, Vascular Function in Healthy Volunteers, Exercise Performance, Safety and Tolerability in Healthy Volunteers
Conditions
Keywords
Exercise performance, Vascular function, blood pressure control, Lentil protein hydrolysate
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.
Interventions
DIETARY_SUPPLEMENTLentil protein hydrolysate
Plant protein hydrolysate
DIETARY_SUPPLEMENTPlacebo MCC micro-crystalline cellulose
Placebo MCC micro-crystalline cellulose
Sponsors
Australian Catholic University
Baker Heart and Diabetes Institute
Nuritas Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Intervention model description
Randomized, double-blind, placebo-controlled, parallel dose response study conducted over 28 days
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting | Day 1 to Day 28 | Change from baseline to the end of the study period in safety via adverse event frequency and severity between placebo and a dose range of Lentil protein hydrolysate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording | Day 1 to Day 28 | Elevation in resting systolic or diastolic blood pressure \>10mm Hg between baseline and after supplementation with lentil protein hydrolysate or placebo. |
| Safety via electrolytes and liver function tests | Day 1 to Day 28 | Change from baseline to the end of the study period in safety determined by combining results of a full blood test investigating concentration (cells/L) and quantity of red blood cells, white blood cells and platelets, electrolytes (mmol/L) and concentrations of liver function markers (U/L); Albumin, Bilirubin, Alanine aminotransferase (ALT), Aspartate amino transferase (AST), Gamma-glutamyl transferase (GGT) and Alkaline phosphatase (ALP) |
| Arterial stiffness | Day 1 to Day 28 | Change from baseline to the end of the study period in central arterial stiffness, measured via aortic pulse-wave velocity |
| Endothelial function | Day 1 to Day 28 | Change from baseline to the end of the study period in endothelium-dependent vascular function measured by flow-mediated dilation |
| Substrate utilisation during sub-maximal, steady-state exercise | Day 1 to Day 28 | Change from baseline to the end of the study period in the rate of oxygen consumption and the oxidative rate of fat and carbohydrates during steady-state exercise |
| Cardiorespiratory fitness (VO2max) | Day 1 to Day 28 | Change from baseline to the end of the study period in cardiorespiratory fitness measured during a cardiopulmonary exercise test |
| Grip Strength | Day 1 to Day 28 | Change from baseline to the end of the study period in hand grip strength measured via a hand-held dynamometer |
| Markers associated with inflammation via blood test | Day 1 to Day 28 | Change from baseline to the end of the study period in inflammatory Markers such as CRP |
| Blood pressure response to exercise | Day 1 to Day 28 | Change from baseline to the end of the study period in blood pressure response to cardiopulmonary exercise test |
| Quality of life via 12-item Short-Form Health Survey version 2 | Day 1 to Day 28 | Change from baseline to the end of the study period in general health via 12-item Short-Form Health Survey version 2 |
| Fatigue symptoms via Multidimensional Fatigue Inventory | Day 1 to Day 28 | Change from baseline to the end of the study period in fatigue symptoms measured via Multidimensional Fatigue Inventory where scores range from 1 (no fatigue) to 50 (severe fatigue) |
Other
| Measure | Time frame | Description |
|---|---|---|
| Habitual physical activity via wearable device | Day 1 to Day 28 | Change from baseline to the end of the study period in habitual physical activity measured via a 3D accelerometer |
| Sleep biometrics via wearable device | Day 1 to Day 28 | Change from baseline to the end of the study period in biometric measures of sleep quality including heart rate (BPM), heart rate variability (RMSSD) and phases of sleep (mins in REM, deep and light) which will be combined to assess overall impact on sleep score (0-100) and readiness score (0-100). |
Countries
Australia
Contacts
Primary ContactNiamh M Mohan, PhD
Backup ContactBrian Keogh, Phd
Outcome results
None listed