Back to resultsAnalysis 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)
Primary Purpose
Metabolic Syndrome, Predisposition to Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vegetable proteins (VP) rich in leucine, cystein, arginine
Animal proteins (AP)
No protein (T)
Sponsored by
About this trial
This is an interventional basic science trial for Metabolic Syndrome focused on measuring Metabolic syndrome, Endothelial function, Vegetable proteins, Arginine, Cysteine, Leucine, Nutrition assessment, Nutrition physiological phenomena
Eligibility Criteria
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
Sites / Locations
- CHU clermont-ferrand
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Group/Cohort1
Group/Cohort2
Group/Cohort3
Arm Description
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 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 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt without any proteins (T) only once during the visit
Outcomes
Primary Outcome Measures
Brachial artery Flow Mediated Dilation (FMD)
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.
Brachial artery Flow Mediated Dilation (FMD)
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.
Brachial artery Flow Mediated Dilation (FMD)
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.
Brachial artery Flow Mediated Dilation (FMD)
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.
Brachial artery Flow Mediated Dilation (FMD)
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.
Brachial artery Flow Mediated Dilation (FMD)
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.
Brachial artery Flow Mediated Dilation (FMD)
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.
Brachial artery Flow Mediated Dilation (FMD)
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.
Brachial artery Flow Mediated Dilation (FMD)
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.
Secondary Outcome Measures
Rest flow by Flowmetry Laser Doppler (FLD)
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.
Occlusion area by FLD
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.
Hyperaemia area by FLD
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.
Hyperaemia area / occlusion area ratio by FLD
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.
Maximal flow by FLD
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.
Hyperaemia half time by FLD
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.
Reactive Hyperemia - Peripheral Arterial Tonometry (RH-PAT)
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.
Plasma nitrite dosage
Determination of nitrite plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.
Urine nitrite dosage
Determination of nitrite urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.
Plasma nitrate dosage
Determination of nitrate plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.
Urine nitrate dosage
Determination of nitrate urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.
Plasma creatinine dosage
Determination of creatinine plasma concentration (µmol/L) (a biomarker of chronic kidney disease) between T-90min to T360min.
Urine creatinine dosage
Determination of creatinine urine concentration (µmol/L) (a biomarker of chronic kidney disease) between T-60min to T250min.
Plasma malondialdehyde (MDA) dosage
Determination of MDA plasma concentration (nmol/L) (a biomarker of oxidative stress) between T-90min to T360min.
Urine malondialdehyde (MDA) dosage
Determination of MDA urine concentration (nmol/L) (a biomarker of oxidative stress) between T-60min to T250min.
Plasma asymmetric dimethylarginine (ADMA) dosage
Determination of ADMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.
Urine asymmetric dimethylarginine (ADMA) dosage
Determination of ADMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.
Plasma symmetric dimethylarginine (SDMA) dosage
Determination of SDMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.
Urine symmetric dimethylarginine (SDMA) dosage
Determination of SDMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.
Plasma acetyl-lysine dosage
Determination of acetyl-lysine plasma concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-90min to T360min.
Urine symmetric acetyl-lysine dosage
Determination of acetyl-lysine urine concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-60min to T250min
Plasma N-epsilon-carboxy-methyl lysine (CML) dosage
Determination of CML plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.
Urine N-epsilon-carboxy-methyl lysine (CML) dosage
Determination of CML urine concentration (pg/mL) (a biomarker of oxidative stress) between T-60min to T250min.
Plasma N-epsilon-carboxy-ethyl lysine (CEL) dosage
Determination of CEL plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.
Urine N-epsilon-carboxy-ethyl lysine (CEL) dosage
Determination of CEL urine concentration (pg/mL) (a biomarker of oxidative stress) between T-60min to T250min.
Plasma alanine dosage
Determination of alanine plasma concentration (µmol/L) between T-90min to T360min.
Urine alanine dosage
Determination of alanine urine concentration (µmol/L) between T-60min to T250min.
Plasma arginine dosage
Determination of arginine plasma concentration (µmol/L) between T-90min to T360min
Urine arginine dosage
Determination of arginine urine concentration (µmol/L) between T-60min to T250min.
Plasma asparagine dosage
Determination of asparagine plasma concentration (µmol/L) between T-90min to T360min
Urine asparagine dosage
Determination of asparagine urine concentration (µmol/L) between T-60min to T250min.
Plasma aspartic acid dosage
Determination of aspartic acid plasma concentration (µmol/L) between T-90min to T360min.
Urine aspartic acid dosage
Determination of aspartic acid urine concentration (µmol/L) between T-60min to T250min.
Plasma cysteine dosage
Determination of cysteine plasma concentration (µmol/L) between T-90min to T360min.
Urine cysteine dosage
Determination of cysteine urine concentration (µmol/L) between T-60min to T250min
Plasma glutamic acid dosage
Determination of glutamic acid plasma concentration (µmol/L) between T-90min to T360min.
Urine glutamic acid dosage
Determination of glutamic acid urine concentration (µmol/L) between T-60min to T250min.
Plasma glutamine dosage
Determination of glutamine plasma concentration (µmol/L) between T-90min to T360min
Urine glutamine dosage
Determination of glutamine urine concentration (µmol/L) between T-60min to T250min.
Plasma glycine dosage
Determination of glycine plasma concentration (µmol/L) between T-90min to T360min
Urine glycine dosage
Determination of glycine urine concentration (µmol/L) between T-60min to T250min
Plasma histidine dosage
Determination of histidine plasma concentration (µmol/L) between T-90min to T360min
Urine histidine dosage
Determination of histidine urine concentration (µmol/L) between T-60min to T250min
Plasma isoleucine dosage
Determination of isoleucine plasma concentration (µmol/L) between T-90min to T360min.
Urine isoleucine dosage
Determination of isoleucine urine concentration (µmol/L) between T-60min to T250min.
Plasma leucine dosage
Determination of leucine plasma concentration (µmol/L) between T-90min to T360min.
Urine leucine dosage
Determination of leucine urine concentration (µmol/L) between T-60min to T250min.
Plasma lysine dosage
Determination of lysine plasma concentration (µmol/L) between T-90min to T360min.
Urine lysine dosage
Determination of lysine urine concentration (µmol/L) between T-60min to T250min.
Plasma methionine dosage
Determination of methionine plasma concentration (µmol/L) between T-90min to T360min.
Urine methionine dosage
Determination of methionine urine concentration (µmol/L) between T-60min to T250min.
Plasma phenylalanine dosage
Determination of phenylalanine plasma concentration (µmol/L) between T-90min to T360min.
Urine phenylalanine dosage
Determination of phenylalanine urine concentration (µmol/L) between T-60min to T250min.
Plasma proline dosage
Determination of proline plasma concentration (µmol/L) between T-90min to T360min.
Urine proline dosage
Determination of proline urine concentration (µmol/L) between T-60min to T250min.
Plasma serine dosage
Determination of serine plasma concentration (µmol/L) between T-90min to T360min.
Urine serine dosage
Determination of serine urine concentration (µmol/L) between T-60min to T250min.
Plasma threonine dosage
Determination of threonine plasma concentration (µmol/L) between T-90min to T360min.
Urine threonine dosage
Determination of threonine urine concentration (µmol/L) between T-60min to T250min.
Plasma tryptophan dosage
Determination of tryptophan plasma concentration (µmol/L) between T-90min to T360min.
Urine tryptophan dosage
Determination of tryptophan urine concentration (µmol/L) between T-60min to T250min.
Plasma tyrosine dosage
Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.
Urine tyrosine dosage
Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.
Plasma valine dosage
Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.
Urine valine dosage
Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.
Plasma Interleukin 6 (IL-6) dosage
Determination of IL-6 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min
Plasma Interleukin 1 bêta (IL-1β) dosage
Determination of IL-1β plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
Plasma Monocyte Chemoattractant Protein-1 (MCP-1) dosage
Determination of MCP-1 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
Plasma Tumor Necrosis Factor alpha (TNFα) dosage
Determination of TNFα plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
Plasma InterCellular Adhesion Molecule 1 (ICAM-1) dosage
Determination of ICAM-1 plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.
Plasma E-Selectine dosage
Determination of E-Selectine plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.
Transcriptome Sequencing of Peripheral Blood Mononuclear Cells
Transcriptomic Analysis to quantify sets of genes involved in endothelial activation, oxidative stress, inflammation and cytokine expression between T-90 min to T360min.
Metabolome Sequencing of Plasma
Untargeted Metabolomics to identify and quantify molecules involved in endothelial activation, oxidative stress, inflammation and cytokine expression between T-90 min to T360min.
Plasma Glucose dosage
Determination of glucose plasma concentration (mg/dl) between T-90min to T360min.
Plasma triglycerides dosage
Determination of triglycerides plasma concentration (mg/dl) between T-90min to T360min.
Plasma insulin dosage
Determination of insulin plasma concentration (pmol/L) between T-90min to T360min
blood Peripheral Blood Mononuclear Cells (PBMC) count
Determination of PBMC count (/mm3) and phenotyping between T-90min to T360min.
PBMC production of Reactive Oxygen Species (ROS)
Assessment of the ROS level (between T-90min to T360min) produced by isolated PBMC following oxidative stress induction.
Questionnaire of acceptability
Acceptability was assessed by a 9-point time scale where "1" means a very poor acceptability and "9" means a very good acceptability.
Full Information
NCT ID
NCT04923555
First Posted
June 1, 2021
Last Updated
June 10, 2022
Sponsor
University Hospital, Clermont-Ferrand
1. Study Identification
Unique Protocol Identification Number
NCT04923555
Brief Title
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
Acronym
P-PROBS CM
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Predisposition to Cardiovascular Disease
Keywords
Metabolic syndrome, Endothelial function, Vegetable proteins, Arginine, Cysteine, Leucine, Nutrition assessment, Nutrition physiological phenomena
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Product kit (yogurt) will be labelled and packaged according to the pre-established randomization plane by the pharmacy department of University Hospital of Clermont-Ferrand, France. Kits will be distributed in a blind fashion for each cross over period on the basis of the randomization schedule.
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group/Cohort1
Arm Type
Experimental
Arm Description
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
Arm Title
Group/Cohort2
Arm Type
Experimental
Arm Description
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
Arm Title
Group/Cohort3
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
Vegetable proteins (VP) rich in leucine, cystein, arginine
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Animal proteins (AP)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No protein (T)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 0 (V1) at T-30min
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 0 (V1) at T180min
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 0 (V1) at T300min
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 28 (V2) at T-30min
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 28 (V2) at T180min
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 28 (V2) at T300min
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 56 (V3) at T-30min
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 56 (V3) at T180min
Title
Brachial artery Flow Mediated Dilation (FMD)
Description
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.
Time Frame
Day 56 (V3) at T300min
Secondary Outcome Measure Information:
Title
Rest flow by Flowmetry Laser Doppler (FLD)
Description
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.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Occlusion area by FLD
Description
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.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Hyperaemia area by FLD
Description
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.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Hyperaemia area / occlusion area ratio by FLD
Description
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.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Maximal flow by FLD
Description
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.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Hyperaemia half time by FLD
Description
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.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Reactive Hyperemia - Peripheral Arterial Tonometry (RH-PAT)
Description
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.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Plasma nitrite dosage
Description
Determination of nitrite plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Urine nitrite dosage
Description
Determination of nitrite urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Plasma nitrate dosage
Description
Determination of nitrate plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Urine nitrate dosage
Description
Determination of nitrate urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Plasma creatinine dosage
Description
Determination of creatinine plasma concentration (µmol/L) (a biomarker of chronic kidney disease) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Urine creatinine dosage
Description
Determination of creatinine urine concentration (µmol/L) (a biomarker of chronic kidney disease) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Plasma malondialdehyde (MDA) dosage
Description
Determination of MDA plasma concentration (nmol/L) (a biomarker of oxidative stress) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Urine malondialdehyde (MDA) dosage
Description
Determination of MDA urine concentration (nmol/L) (a biomarker of oxidative stress) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Plasma asymmetric dimethylarginine (ADMA) dosage
Description
Determination of ADMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Urine asymmetric dimethylarginine (ADMA) dosage
Description
Determination of ADMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Plasma symmetric dimethylarginine (SDMA) dosage
Description
Determination of SDMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Urine symmetric dimethylarginine (SDMA) dosage
Description
Determination of SDMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Plasma acetyl-lysine dosage
Description
Determination of acetyl-lysine plasma concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Title
Urine symmetric acetyl-lysine dosage
Description
Determination of acetyl-lysine urine concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-60min to T250min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma N-epsilon-carboxy-methyl lysine (CML) dosage
Description
Determination of CML plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine N-epsilon-carboxy-methyl lysine (CML) dosage
Description
Determination of CML urine concentration (pg/mL) (a biomarker of oxidative stress) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma N-epsilon-carboxy-ethyl lysine (CEL) dosage
Description
Determination of CEL plasma concentration (pg/mL) (a biomarker of oxidative stress) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine N-epsilon-carboxy-ethyl lysine (CEL) dosage
Description
Determination of CEL urine concentration (pg/mL) (a biomarker of oxidative stress) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma alanine dosage
Description
Determination of alanine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine alanine dosage
Description
Determination of alanine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma arginine dosage
Description
Determination of arginine plasma concentration (µmol/L) between T-90min to T360min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine arginine dosage
Description
Determination of arginine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma asparagine dosage
Description
Determination of asparagine plasma concentration (µmol/L) between T-90min to T360min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine asparagine dosage
Description
Determination of asparagine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma aspartic acid dosage
Description
Determination of aspartic acid plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine aspartic acid dosage
Description
Determination of aspartic acid urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma cysteine dosage
Description
Determination of cysteine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine cysteine dosage
Description
Determination of cysteine urine concentration (µmol/L) between T-60min to T250min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma glutamic acid dosage
Description
Determination of glutamic acid plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine glutamic acid dosage
Description
Determination of glutamic acid urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma glutamine dosage
Description
Determination of glutamine plasma concentration (µmol/L) between T-90min to T360min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine glutamine dosage
Description
Determination of glutamine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma glycine dosage
Description
Determination of glycine plasma concentration (µmol/L) between T-90min to T360min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine glycine dosage
Description
Determination of glycine urine concentration (µmol/L) between T-60min to T250min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma histidine dosage
Description
Determination of histidine plasma concentration (µmol/L) between T-90min to T360min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine histidine dosage
Description
Determination of histidine urine concentration (µmol/L) between T-60min to T250min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma isoleucine dosage
Description
Determination of isoleucine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine isoleucine dosage
Description
Determination of isoleucine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma leucine dosage
Description
Determination of leucine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine leucine dosage
Description
Determination of leucine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma lysine dosage
Description
Determination of lysine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine lysine dosage
Description
Determination of lysine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma methionine dosage
Description
Determination of methionine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine methionine dosage
Description
Determination of methionine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma phenylalanine dosage
Description
Determination of phenylalanine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine phenylalanine dosage
Description
Determination of phenylalanine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma proline dosage
Description
Determination of proline plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine proline dosage
Description
Determination of proline urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma serine dosage
Description
Determination of serine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine serine dosage
Description
Determination of serine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma threonine dosage
Description
Determination of threonine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine threonine dosage
Description
Determination of threonine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma tryptophan dosage
Description
Determination of tryptophan plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine tryptophan dosage
Description
Determination of tryptophan urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma tyrosine dosage
Description
Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine tyrosine dosage
Description
Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma valine dosage
Description
Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Urine valine dosage
Description
Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma Interleukin 6 (IL-6) dosage
Description
Determination of IL-6 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma Interleukin 1 bêta (IL-1β) dosage
Description
Determination of IL-1β plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma Monocyte Chemoattractant Protein-1 (MCP-1) dosage
Description
Determination of MCP-1 plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma Tumor Necrosis Factor alpha (TNFα) dosage
Description
Determination of TNFα plasma concentration (pg/ml) (a biomarker of inflammation and oxidative stress) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma InterCellular Adhesion Molecule 1 (ICAM-1) dosage
Description
Determination of ICAM-1 plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma E-Selectine dosage
Description
Determination of E-Selectine plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Transcriptome Sequencing of Peripheral Blood Mononuclear Cells
Description
Transcriptomic Analysis to quantify sets of genes involved in endothelial activation, oxidative stress, inflammation and cytokine expression between T-90 min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Metabolome Sequencing of Plasma
Description
Untargeted Metabolomics to identify and quantify molecules involved in endothelial activation, oxidative stress, inflammation and cytokine expression between T-90 min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma Glucose dosage
Description
Determination of glucose plasma concentration (mg/dl) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma triglycerides dosage
Description
Determination of triglycerides plasma concentration (mg/dl) between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Plasma insulin dosage
Description
Determination of insulin plasma concentration (pmol/L) between T-90min to T360min
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
blood Peripheral Blood Mononuclear Cells (PBMC) count
Description
Determination of PBMC count (/mm3) and phenotyping between T-90min to T360min.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
PBMC production of Reactive Oxygen Species (ROS)
Description
Assessment of the ROS level (between T-90min to T360min) produced by isolated PBMC following oxidative stress induction.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
Title
Questionnaire of acceptability
Description
Acceptability was assessed by a 9-point time scale where "1" means a very poor acceptability and "9" means a very good acceptability.
Time Frame
Day 0 (V1), Day 28 (V2), Day 56 (V3).
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gisèle PICKERING
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU clermont-ferrand
City
Clermont-Ferrand
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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