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Набира участници Не е приложимо NCT06894875

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

Не е приложима фаза (напр. обсервационно)
Заболявания: Exercise Blood Pressure Vasodilation Vascular Function in Healthy Volunteers Exercise Performance Safety and Tolerability in Healthy Volunteers

Спонсор: Nuritas Ltd

Налично на: БГ
Обобщение
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
Описание
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.
Кой може да участва
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.
Места на провеждане 1
Австралия (1)
Baker Heart and Diabetes Institute
Melbourne , Victoria
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
45 Years
Здрави доброволци
Не
Начална дата
24.06.2025
Крайна дата
30.03.2026
Регистрационен номер
NCT06894875
Източник
anzctr
Запитване за медицински туризъм

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