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)
2026年8月3日 更新者：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.
調査の概要
状態
完了
詳細な説明
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.
研究の種類
介入
入学 (実際)
33
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
-
Clermont-Ferrand、フランス
- CHU clermont-ferrand
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
65年歳以上 (高齢者)
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
プラセボコンパレーター：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.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Brachial artery Flow Mediated Dilation (FMD)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Rest flow by Flowmetry Laser Doppler (FLD)
時間枠：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
時間枠：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
時間枠：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)
|
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Hyperaemia area / occlusion area ratio by FLD
時間枠：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)
|
|
Maximal flow by FLD
時間枠：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)
|
|
Hyperaemia half time by FLD
時間枠：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)
|
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Reactive Hyperemia - Peripheral Arterial Tonometry (RH-PAT)
時間枠：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.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Plasma nitrite dosage
時間枠：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.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Urine nitrite dosage
時間枠：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.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Plasma nitrate dosage
時間枠：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
時間枠：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.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Plasma creatinine dosage
時間枠：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
時間枠：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
時間枠：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
時間枠：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.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
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Plasma asymmetric dimethylarginine (ADMA) dosage
時間枠：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.
|
Day 0 (V1), Day 28 (V2), Day 56 (V3)
|
|
Urine asymmetric dimethylarginine (ADMA) dosage
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
|
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Urine symmetric acetyl-lysine dosage
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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).
|
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Plasma asparagine dosage
時間枠：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).
|
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Urine asparagine dosage
時間枠：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).
|
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Plasma aspartic acid dosage
時間枠：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).
|
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Urine aspartic acid dosage
時間枠：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
時間枠：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
時間枠：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
時間枠：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).
|
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Urine glutamic acid dosage
時間枠：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).
|
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Plasma glutamine dosage
時間枠：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).
|
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Urine glutamine dosage
時間枠：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
時間枠：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
時間枠：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).
|
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Plasma histidine dosage
時間枠：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).
|
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Urine histidine dosage
時間枠：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).
|
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Plasma isoleucine dosage
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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).
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Gisèle PICKERING、University Hospital, Clermont-Ferrand
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2021年11月9日
一次修了 (実際)
2022年6月7日
研究の完了 (実際)
2022年6月7日
試験登録日
最初に提出
2021年6月1日
QC基準を満たした最初の提出物
2021年6月10日
最初の投稿 (実際)
2021年6月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年8月5日
QC基準を満たした最後の更新が送信されました
2026年8月3日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- RBHP 2021 PICKERING
- 2021-A00134-37 (その他の識別子：2021-A00134-37)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。