Analysis of the Postprandial Effects of a Vegetable Protein Mixture Rich in Arginine, Cysteine and Leucine on Endothelial Dysfunction and Inflammation at Low Noise in Elderly People With Cardiometabolic Risk (P-PROBS CM)
10 июня 2022 г. обновлено: University Hospital, Clermont-Ferrand
By 2050, the expanding world population will consume two-thirds more animal protein than it consumes today.
The increase in chronic diseases associated with the generalization of these consumption patterns tend to understand the place of meat in our diets.
All these elements participate to the reduction of animal proteins in favor of vegetable proteins in our food.
The elderly are particularly affected by malnutrition, the prevalence of protein-energy malnutrition increasing with age and promoting the onset of morbidities.
Without care, it leads to the worsening of physiological phenomena linked to aging such as loss of muscle functionality (sarcopenia) or reduction in bone density (osteoporosis) and increases the risk of falls - the main cause of dependence.
However, in France, protein consumption declines significantly with age, even though requirements appear to be greater for the elderly.
It is therefore a major challenge for our societies to ensure that the aging of the population and the increase in life expectancy are not synonymous with a reduction in the physical and mental capacities of individuals.
Thus, it is essential to ensure that the recommendations for reducing the intake of animal proteins in favor of vegetable proteins can be applied without risk to aging populations, in particular on the human body cardiovascular risk of these populations.
Обзор исследования
Статус
Завершенный
Подробное описание
This human dietary intervention study is a double blind, randomized, placebo controlled, cross over trial with 3 arms, carried out on subjects with predisposition to cardiometabolic syndrome (based on weight circumference, blood triglyceride or blood cholesterol, glycemia and hypertension). This study aims to demonstrate transient improvement in vascular endothelial function (with Flow Mediated Dilatation (FMD) as main criteria) with consumption of vegetable proteins (rich in leucine, cysteine and arginine) by comparison with animal proteins and with a control without proteins.
The 33 recruited participants will receive the 3 yogurts in a random order. For each subject, the study is divided into 4 visits.
To summarize: Visit 1 (D-7) = inclusion, Visit 2 (D0: treatment period N°1), Visit 3 (D28 : treatment period N°2), Visit 4 (D56 : treatment period N°3). The wash-out periods between treatment period (duration: 4 weeks) may be extended until 5 weeks for the convenience of participants.
The protocol includes a total of 4 visits to PIC/CIC Inserm 1405 of the Clermont-Fd University Hospital.
Тип исследования
Интервенционный
Регистрация (Действительный)
33
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Места учебы
-
-
-
Clermont-Ferrand, Франция
- CHU Clermont-Ferrand
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
65 лет и старше (Пожилой взрослый)
Принимает здоровых добровольцев
Да
Полы, имеющие право на обучение
Все
Описание
Inclusion Criteria:
- Man or woman
- 65 years old and older (inclusive)
At least 2 of the following 4 cardiometabolic factors:
- Waist circumference ≥88 cm for women, and ≥94 cm for men
- Fasting triglyceridemia >1,5 g/L OR HDL level < 40 mg/dl for men, and < 50 mg/dl for women
- Fasting blood glucose ≥ 100 mg/dl
- Systolic blood pressure >130mmHg ou diastolic > 85 mm Hg
- Accept not to change his lifestyle throughout the study
- Accept to consume the same meal the day before exploration days, making sure to exclude non-recommended foods and agreeing to detail its content in a food diary
- Ability to give informed consent to participate in research
- Affiliation to Social Security
Exclusion Criteria:
- Acute pathology (unstable or terminal pathology)
- Renal failure (clearance <40 mL / min)
- Asthma or chronic respiratory disease
- Systolic or diastolic blood pressure in the judgement of the investigator
- Diabetic (treated or not)
- Treated with chemotherapy
- Gastrointestinal, thyroid, cardiac or vascular illness in the judgement of the investigator
- Biological examination no compatible with the study in the judgement of the investigator
- Medical and/or surgical history no compatible with the study in the judgement of the investigator (previous cardiovascular events)
- AgHbS, AcHbc, HCV and HIV positive serology
- Concomitant treatment no compatible with the study in the judgement of the investigator
- Diet or change in body mass > 2 kg in the 30 days before the study
- Following a diet incompatible with the nutritional protocol (food intolerances, vegans, exclusion of certain food ingredients)
- Allergies to any of the components of the test meals
- Alcohol consumption> 2 glasses / day
- Current smokers (> 6 cigarettes per week)
- Subjects involved in another clinical trial or being in the exclusion period of another study or having received a total compensation greater than 4,500 euros over the 12 months preceding the start of the trial
- Subject benefiting from a legal protection measure (curatorship, guardianship, safeguard of justice)
- Refusal to participate
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Фундаментальная наука
- Распределение: Рандомизированный
- Интервенционная модель: Назначение кроссовера
- Маскировка: Четырехместный
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: Group/Cohort1
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in cysteine, leucine and arginine (VP, vegetable proteins) only once during the visit
|
33 volunteers will consume 400 ml of yogurt with vegetable proteins (VP) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of vegetable proteins.
33 volunteers will consume 400 ml of yogurt with animal proteins (AP) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
33 volunteers will consume 400 ml of yogurt without any protein (T) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
|
|
Экспериментальный: Group/Cohort2
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in animal proteins (AP) only once during the visit
|
33 volunteers will consume 400 ml of yogurt with vegetable proteins (VP) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of vegetable proteins.
33 volunteers will consume 400 ml of yogurt with animal proteins (AP) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
33 volunteers will consume 400 ml of yogurt without any protein (T) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
|
|
Плацебо Компаратор: Group/Cohort3
33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt without any proteins (T) only once during the visit
|
33 volunteers will consume 400 ml of yogurt with vegetable proteins (VP) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of vegetable proteins.
33 volunteers will consume 400 ml of yogurt with animal proteins (AP) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
33 volunteers will consume 400 ml of yogurt without any protein (T) rich in leucine, cystein and arginine only once during the visit.
At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 0 (V1) at T-30min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized.
|
Day 0 (V1) at T-30min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 0 (V1) at T180min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
|
Day 0 (V1) at T180min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 0 (V1) at T300min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
|
Day 0 (V1) at T300min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 28 (V2) at T-30min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
|
Day 28 (V2) at T-30min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 28 (V2) at T180min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
|
Day 28 (V2) at T180min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 28 (V2) at T300min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
|
Day 28 (V2) at T300min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 56 (V3) at T-30min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
|
Day 56 (V3) at T-30min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 56 (V3) at T180min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
|
Day 56 (V3) at T180min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Временное ограничение: Day 56 (V3) at T300min
|
The endothelial function will be assessed using the non-invasive ultrasound technique of flow mediated dilatation of the brachial artery.
FMD measure is the percentage of dilation of brachial artery in response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery realized between T-30min to T300min.
|
Day 56 (V3) at T300min
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Rest flow by Flowmetry Laser Doppler (FLD)
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the rest flow using laser-Doppler system at the level of the skin of the hand realized between T-30min to T300min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Occlusion area by FLD
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the occlusion area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) realized between T-30min to T300min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Hyperaemia area by FLD
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia area using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) realized between T-30min to T300min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Hyperaemia area / occlusion area ratio by FLD
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Vascular endothelial function in the micro-vascular compartment will be assessed using the ratio hyperaemia area / occlusion area determined by FLD realized between T-30min to T300min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Maximal flow by FLD
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the maximal flow using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) realized between T-30min to T300min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Hyperaemia half time by FLD
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Vascular endothelial function in the micro-vascular compartment will be assessed using the measurement of the hyperaemia half time using laser-Doppler system at the level of the skin of the hand by following the response to a reactive hyperaemia induced by the release of a transient occlusion of the brachial artery (same stimulus as for FMD measurement) realized between T-30min to T300min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Reactive Hyperemia - Peripheral Arterial Tonometry (RH-PAT)
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Reactive hyperemia index (RHI) assessed by reactive hyperemia-peripheral arterial tonometry (RH-PAT) expressed as a percentage measures pulsatile fluctuations in digital volume in response to a reactive hyperaemia induced by the release of a transient occlusion realized between T-30min to T300min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Plasma nitrite dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of nitrite plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Urine nitrite dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of nitrite urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Plasma nitrate dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of nitrate plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Urine nitrate dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of nitrate urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Plasma creatinine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of creatinine plasma concentration (µmol/L) (a biomarker of chronic kidney disease) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Urine creatinine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of creatinine urine concentration (µmol/L) (a biomarker of chronic kidney disease) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Plasma malondialdehyde (MDA) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of MDA plasma concentration (nmol/L) (a biomarker of oxidative stress) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Urine malondialdehyde (MDA) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of MDA urine concentration (nmol/L) (a biomarker of oxidative stress) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Plasma asymmetric dimethylarginine (ADMA) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of ADMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Urine asymmetric dimethylarginine (ADMA) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of ADMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Plasma symmetric dimethylarginine (SDMA) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of SDMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Urine symmetric dimethylarginine (SDMA) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of SDMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Plasma acetyl-lysine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
Determination of acetyl-lysine plasma concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Urine symmetric acetyl-lysine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of acetyl-lysine urine concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-60min to T250min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma N-epsilon-carboxy-methyl lysine (CML) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of CML plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine N-epsilon-carboxy-methyl lysine (CML) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of CML urine concentration (pg/mL) (a biomarker of oxidative stress) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma N-epsilon-carboxy-ethyl lysine (CEL) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of CEL plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine N-epsilon-carboxy-ethyl lysine (CEL) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of CEL urine concentration (pg/mL) (a biomarker of oxidative stress) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma alanine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of alanine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine alanine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of alanine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma arginine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of arginine plasma concentration (µmol/L) between T-90min to T360min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine arginine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of arginine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma asparagine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of asparagine plasma concentration (µmol/L) between T-90min to T360min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine asparagine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of asparagine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma aspartic acid dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of aspartic acid plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine aspartic acid dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of aspartic acid urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma cysteine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of cysteine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine cysteine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of cysteine urine concentration (µmol/L) between T-60min to T250min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma glutamic acid dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of glutamic acid plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine glutamic acid dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of glutamic acid urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma glutamine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of glutamine plasma concentration (µmol/L) between T-90min to T360min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine glutamine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of glutamine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma glycine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of glycine plasma concentration (µmol/L) between T-90min to T360min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine glycine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of glycine urine concentration (µmol/L) between T-60min to T250min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma histidine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of histidine plasma concentration (µmol/L) between T-90min to T360min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine histidine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of histidine urine concentration (µmol/L) between T-60min to T250min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma isoleucine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of isoleucine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine isoleucine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of isoleucine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma leucine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of leucine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine leucine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of leucine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma lysine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of lysine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine lysine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of lysine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma methionine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of methionine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine methionine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of methionine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma phenylalanine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of phenylalanine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine phenylalanine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of phenylalanine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma proline dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of proline plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine proline dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of proline urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma serine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of serine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine serine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of serine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma threonine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of threonine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine threonine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of threonine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma tryptophan dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of tryptophan plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine tryptophan dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of tryptophan urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma tyrosine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine tyrosine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma valine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Urine valine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma Interleukin 6 (IL-6) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of IL-6 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma Interleukin 1 bêta (IL-1β) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of IL-1β plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma Monocyte Chemoattractant Protein-1 (MCP-1) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of MCP-1 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma Tumor Necrosis Factor alpha (TNFα) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of TNFα plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma InterCellular Adhesion Molecule 1 (ICAM-1) dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of ICAM-1 plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma E-Selectine dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of E-Selectine plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Transcriptome Sequencing of Peripheral Blood Mononuclear Cells
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Transcriptomic Analysis to quantify sets of genes involved in endothelial activation, oxidative stress, inflammation and cytokine expression between T-90 min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Metabolome Sequencing of Plasma
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Untargeted Metabolomics to identify and quantify molecules involved in endothelial activation, oxidative stress, inflammation and cytokine expression between T-90 min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma Glucose dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of glucose plasma concentration (mg/dl) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma triglycerides dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of triglycerides plasma concentration (mg/dl) between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Plasma insulin dosage
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of insulin plasma concentration (pmol/L) between T-90min to T360min
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
blood Peripheral Blood Mononuclear Cells (PBMC) count
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of PBMC count (/mm3) and phenotyping between T-90min to T360min.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
PBMC production of Reactive Oxygen Species (ROS)
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Assessment of the ROS level (between T-90min to T360min) produced by isolated PBMC following oxidative stress induction.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
|
Questionnaire of acceptability
Временное ограничение: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Acceptability was assessed by a 9-point time scale where "1" means a very poor acceptability and "9" means a very good acceptability.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
9 ноября 2021 г.
Первичное завершение (Действительный)
7 июня 2022 г.
Завершение исследования (Действительный)
7 июня 2022 г.
Даты регистрации исследования
Первый отправленный
1 июня 2021 г.
Впервые представлено, что соответствует критериям контроля качества
10 июня 2021 г.
Первый опубликованный (Действительный)
11 июня 2021 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
13 июня 2022 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
10 июня 2022 г.
Последняя проверка
1 июня 2022 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- RBHP 2021 PICKERING
- 2021-A00134-37 (Другой идентификатор: 2021-A00134-37)
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .