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

Официальное название

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

Обзор

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

Подробное 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.

Вмешательства

• Пищевая добавка Lentil protein hydrolysate
  Plant protein hydrolysate
• Пищевая добавка Placebo MCC micro-crystalline cellulose
  Placebo MCC micro-crystalline cellulose

Первичные конечные точки

• Safety and Tolerability of a dose range of Lentil protein hydrolyste via adverse event reporting [Срок оценки: Day 1 to Day 28]

Вторичные конечные точки (12)

• Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording [Срок оценки: Day 1 to Day 28]
• Safety and Tolerability of a dose range of Lentil protein hydrolyste via blood pressure recording [Срок оценки: Day 1]
• Safety via electrolytes and liver function tests [Срок оценки: Day 1 to Day 28]
• Arterial stiffness [Срок оценки: Day 1 to Day 28]
• Endothelial function [Срок оценки: Day 1 to Day 28]
• Substrate utilisation during sub-maximal, steady-state exercise [Срок оценки: Day 1 to Day 28]
• Cardiorespiratory fitness (VO2max) [Срок оценки: Day 1 to Day 28]
• Blood pressure response to exercise [Срок оценки: Day 1 to Day 28]
• Quality of life via 12-item Short-Form Health Survey version 2 [Срок оценки: Day 1 to Day 28]
• Fatigue symptoms via Multidimensional Fatigue Inventory [Срок оценки: Day 1 to Day 28]
• Grip Strength [Срок оценки: Day 1 to Day 28]
• Markers associated with inflammation via blood test [Срок оценки: Day 1 to Day 28]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Другое

Центры проведения

Австралия · 1 центр

• Baker Heart and Diabetes Institute — Melbourne

Идентификаторы

NCT: NCT06894875 · PEPLEN24

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗