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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
OTHER
Phase
- NA
Study ID
NCT06894875
Intervention or treatment
DIETARY_SUPPLEMENT: Lentil protein hydrolysate
DIETARY_SUPPLEMENT: Placebo MCC micro-crystalline cellulose
Conditions
- Exercise
- Blood Pressure
- Vasodilation
- Vascular Function in Healthy Volunteers
- Exercise Performance
- Safety and Tolerability in Healthy Volunteers
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Baker Heart and Diabetes Institute
Select from list below to view details:
Baker Heart and Diabetes Institute
Melbourne, Victoria, Australia
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Who is running the clinical trial?
Nuritas Ltd
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
| Participant Group/Arm | Intervention/Treatment |
|---|---|
EXPERIMENTAL: Lentil protein hydrolysate 500 mg/day
| Dietary Supplement: Lentil protein hydrolysate |
EXPERIMENTAL: Lentil protein hydrolysate 1000 mg/day
| Dietary Supplement: Lentil protein hydrolysate |
EXPERIMENTAL: Lentil protein hydrolysate 2000 mg/day
| Dietary Supplement: Lentil protein hydrolysate |
PLACEBO_COMPARATOR: Microcrystalline Cellulose 2000mg/day
| Dietary Supplement: Placebo MCC micro-crystalline cellulose |
What is the study measuring?
Primary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting | 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 | Day 1 to Day 28 |
Secondary Outcome
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording | Elevation in resting systolic or diastolic blood pressure \>10mm Hg between baseline and after supplementation with lentil protein hydrolysate or placebo. | Day 1 to Day 28 |
| Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording | Decrease in systolic (\>20mmHg) or diastolic (\>10mmHg) blood pressure upon standing after acute supplementation with lentil protein hydrolysate or placebo. | Day 1 |
| Safety via electrolytes and liver function tests | 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) | Day 1 to Day 28 |
| Arterial stiffness | Change from baseline to the end of the study period in central arterial stiffness, measured via aortic pulse-wave velocity | Day 1 to Day 28 |
| Endothelial function | Change from baseline to the end of the study period in endothelium-dependent vascular function measured by flow-mediated dilation | Day 1 to Day 28 |
| Substrate utilisation during sub-maximal, steady-state exercise | 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 | Day 1 to Day 28 |
| Cardiorespiratory fitness (VO2max) | Change from baseline to the end of the study period in cardiorespiratory fitness measured during a cardiopulmonary exercise test | Day 1 to Day 28 |
| Blood pressure response to exercise | Change from baseline to the end of the study period in blood pressure response to cardiopulmonary exercise test | Day 1 to Day 28 |
| Quality of life via 12-item Short-Form Health Survey version 2 | Change from baseline to the end of the study period in general health via 12-item Short-Form Health Survey version 2 | Day 1 to Day 28 |
| Fatigue symptoms via Multidimensional Fatigue Inventory | 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) | Day 1 to Day 28 |
| Grip Strength | Change from baseline to the end of the study period in hand grip strength measured via a hand-held dynamometer | Day 1 to Day 28 |
| Markers associated with inflammation via blood test | Change from baseline to the end of the study period in inflammatory Markers such as CRP | Day 1 to Day 28 |
References
Clinical Trials Gov: Effects of Lentil Protein Hydrolysate on Blood Pressure Control, Vascular Function and Exercise PerformanceOther trials to consider
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