An interventional study of Vegetable proteins (VP) rich in leucine, cystein, arginine and Animal proteins (AP) in Metabolic Syndrome and Predisposition to Cardiovascular Disease, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-05.
Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Basic science
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.
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.
1,964 studies on the registry are indexed under Metabolic Syndrome; 330 are open to participants now.
This study's enrollment of 33 is below the median of 60 across 1,460 interventional studies indexed under Metabolic Syndrome.
Browse Metabolic Syndrome studies →University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least 2 of the following 4 cardiometabolic factors:
Exclusion Criteria:
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
Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine · Behavioral: Animal proteins (AP) · Behavioral: No protein (T)
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
Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine · Behavioral: Animal proteins (AP) · Behavioral: No protein (T)
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
Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine · Behavioral: Animal proteins (AP) · Behavioral: No protein (T)
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.
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.
Time frame: Day 0 (V1) at T-30min
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.
Time frame: Day 0 (V1) at T180min
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.
Time frame: Day 0 (V1) at 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.
Time frame: Day 28 (V2) at T-30min
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.
Time frame: Day 28 (V2) at T180min
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.
Time frame: Day 28 (V2) at 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.
Time frame: Day 56 (V3) at T-30min
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.
Time frame: Day 56 (V3) at T180min
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.
Time frame: Day 56 (V3) at T300min
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3)
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3)
Plasma nitrite dosage
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)
Urine nitrite dosage
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)
Plasma nitrate dosage
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)
Urine nitrate dosage
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)
Plasma creatinine dosage
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)
Urine creatinine dosage
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)
Plasma malondialdehyde (MDA) dosage
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)
Urine malondialdehyde (MDA) dosage
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)
Plasma asymmetric dimethylarginine (ADMA) dosage
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)
Urine asymmetric dimethylarginine (ADMA) dosage
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)
Plasma symmetric dimethylarginine (SDMA) dosage
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)
Urine symmetric dimethylarginine (SDMA) dosage
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)
Plasma acetyl-lysine dosage
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)
Urine symmetric acetyl-lysine dosage
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).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma alanine dosage
Determination of alanine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine alanine dosage
Determination of alanine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma arginine dosage
Determination of arginine plasma concentration (µmol/L) between T-90min to T360min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine arginine dosage
Determination of arginine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma asparagine dosage
Determination of asparagine plasma concentration (µmol/L) between T-90min to T360min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine asparagine dosage
Determination of asparagine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma aspartic acid dosage
Determination of aspartic acid plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine aspartic acid dosage
Determination of aspartic acid urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma cysteine dosage
Determination of cysteine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine cysteine dosage
Determination of cysteine urine concentration (µmol/L) between T-60min to T250min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma glutamic acid dosage
Determination of glutamic acid plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine glutamic acid dosage
Determination of glutamic acid urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma glutamine dosage
Determination of glutamine plasma concentration (µmol/L) between T-90min to T360min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine glutamine dosage
Determination of glutamine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma glycine dosage
Determination of glycine plasma concentration (µmol/L) between T-90min to T360min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine glycine dosage
Determination of glycine urine concentration (µmol/L) between T-60min to T250min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma histidine dosage
Determination of histidine plasma concentration (µmol/L) between T-90min to T360min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine histidine dosage
Determination of histidine urine concentration (µmol/L) between T-60min to T250min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma isoleucine dosage
Determination of isoleucine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine isoleucine dosage
Determination of isoleucine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma leucine dosage
Determination of leucine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine leucine dosage
Determination of leucine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma lysine dosage
Determination of lysine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine lysine dosage
Determination of lysine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma methionine dosage
Determination of methionine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine methionine dosage
Determination of methionine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma phenylalanine dosage
Determination of phenylalanine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine phenylalanine dosage
Determination of phenylalanine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma proline dosage
Determination of proline plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine proline dosage
Determination of proline urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma serine dosage
Determination of serine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine serine dosage
Determination of serine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma threonine dosage
Determination of threonine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine threonine dosage
Determination of threonine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma tryptophan dosage
Determination of tryptophan plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine tryptophan dosage
Determination of tryptophan urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma tyrosine dosage
Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine tyrosine dosage
Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma valine dosage
Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Urine valine dosage
Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma E-Selectine dosage
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).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma Glucose dosage
Determination of glucose plasma concentration (mg/dl) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma triglycerides dosage
Determination of triglycerides plasma concentration (mg/dl) between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
Plasma insulin dosage
Determination of insulin plasma concentration (pmol/L) between T-90min to T360min
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
blood Peripheral Blood Mononuclear Cells (PBMC) count
Determination of PBMC count (/mm3) and phenotyping between T-90min to T360min.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
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.
Time frame: Day 0 (V1), Day 28 (V2), Day 56 (V3).
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University Hospital, Clermont-Ferrand