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)
3 de agosto de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Actual)
33
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
-
Clermont-Ferrand, Francia
- CHU clermont-ferrand
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
65 años y mayores (Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Ciencia básica
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: 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.
|
|
Experimental: 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.
|
|
Comparador de placebos: 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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 0 (V1) at T-30min
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Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 0 (V1) at T180min
|
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Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 0 (V1) at T300min
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Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 28 (V2) at T-30min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 28 (V2) at T180min
|
|
Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 28 (V2) at T300min
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Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 56 (V3) at T-30min
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|
Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 56 (V3) at T180min
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Brachial artery Flow Mediated Dilation (FMD)
Periodo de tiempo: 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.
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Day 56 (V3) at T300min
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Rest flow by Flowmetry Laser Doppler (FLD)
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Occlusion area by FLD
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Hyperaemia area by FLD
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Hyperaemia area / occlusion area ratio by FLD
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Maximal flow by FLD
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Hyperaemia half time by FLD
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Reactive Hyperemia - Peripheral Arterial Tonometry (RH-PAT)
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Determination of nitrate 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 nitrate dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Determination of creatinine plasma concentration (µmol/L) (a biomarker of chronic kidney disease) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Urine creatinine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Determination of MDA plasma concentration (nmol/L) (a biomarker of oxidative stress) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Urine malondialdehyde (MDA) dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Plasma symmetric dimethylarginine (SDMA) dosage
Periodo de tiempo: 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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Urine symmetric dimethylarginine (SDMA) dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Determination of SDMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Plasma acetyl-lysine dosage
Periodo de tiempo: 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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3)
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Urine symmetric acetyl-lysine dosage
Periodo de tiempo: 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
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma N-epsilon-carboxy-methyl lysine (CML) dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of CML plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine N-epsilon-carboxy-methyl lysine (CML) dosage
Periodo de tiempo: 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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
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Plasma N-epsilon-carboxy-ethyl lysine (CEL) dosage
Periodo de tiempo: 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.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine N-epsilon-carboxy-ethyl lysine (CEL) dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of CEL urine concentration (pg/mL) (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 alanine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of alanine plasma concentration (µmol/L) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine alanine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of alanine urine concentration (µmol/L) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma arginine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of arginine plasma concentration (µmol/L) between T-90min to T360min
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine arginine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of arginine urine concentration (µmol/L) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma asparagine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of asparagine plasma concentration (µmol/L) between T-90min to T360min
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine asparagine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
|
Determination of asparagine urine concentration (µmol/L) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma aspartic acid dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of aspartic acid plasma concentration (µmol/L) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine aspartic acid dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of aspartic acid urine concentration (µmol/L) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma cysteine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of cysteine plasma concentration (µmol/L) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine cysteine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of cysteine urine concentration (µmol/L) between T-60min to T250min
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma glutamic acid dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of glutamic acid plasma concentration (µmol/L) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine glutamic acid dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of glutamic acid urine concentration (µmol/L) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma glutamine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of glutamine plasma concentration (µmol/L) between T-90min to T360min
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine glutamine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of glutamine urine concentration (µmol/L) between T-60min to T250min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma glycine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of glycine plasma concentration (µmol/L) between T-90min to T360min
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine glycine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of glycine urine concentration (µmol/L) between T-60min to T250min
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma histidine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of histidine plasma concentration (µmol/L) between T-90min to T360min
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine histidine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of histidine urine concentration (µmol/L) between T-60min to T250min
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Plasma isoleucine dosage
Periodo de tiempo: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Determination of isoleucine plasma concentration (µmol/L) between T-90min to T360min.
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Day 0 (V1), Day 28 (V2), Day 56 (V3).
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Urine isoleucine dosage
Periodo de tiempo: 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).
|
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Plasma leucine dosage
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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).
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Gisèle PICKERING, University Hospital, Clermont-Ferrand
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
9 de noviembre de 2021
Finalización primaria (Actual)
7 de junio de 2022
Finalización del estudio (Actual)
7 de junio de 2022
Fechas de registro del estudio
Enviado por primera vez
1 de junio de 2021
Primero enviado que cumplió con los criterios de control de calidad
10 de junio de 2021
Publicado por primera vez (Actual)
11 de junio de 2021
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de agosto de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
3 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades metabólicas
- Trastornos del metabolismo de la glucosa
- Resistencia a la insulina
- Hiperinsulinismo
- Enfermedades Nutricionales y Metabólicas
- Síndrome metabólico
- Aminoácidos, péptidos y proteínas
- Proteínas
- Alimento
- Dieta, alimentos y nutrición
- Fenómeno fisiológico
- Comida y bebidas
- Aminoácidos
- Aminoácidos, básicos
- Aminoácidos, diamino
- Aminoácidos, esenciales
- Proteínas dietéticas
- Proteínas vegetales
- Aminoácidos, cadena ramificada
- Arginina
- Leucina
- Plant Proteins, Dietary
- Animal Proteins, Dietary
Otros números de identificación del estudio
- RBHP 2021 PICKERING
- 2021-A00134-37 (Otro identificador: 2021-A00134-37)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .