AzTrials
AzTrials

Metabolic SyndromeP-PROBS CMNCT04923555

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

A study testing Vegetable proteins (VP) rich in leucine, cystein, arginine, Animal proteins (AP) and No protein (T) in people with Metabolic Syndrome and Predisposition to Cardiovascular Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
What is being tested?
Vegetable proteins (VP) rich in leucine, cystein, arginine, Animal proteins (AP) and No protein (T)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
33 participants
Where
1 siteFrance
Study dates
9 Nov 2021to 7 Jun 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 19Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • CHU clermont-ferrand

    Clermont-Ferrand

Other trials in France

About this study

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.

Read the 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.

Being tested
Vegetable proteins (VP) rich in leucine, cystein, arginine, Animal proteins (AP), No protein (T)
Keywords
Metabolic syndrome, Endothelial function, Vegetable proteins, Arginine, Cysteine, Leucine, Nutrition assessment, Nutrition physiological phenomena
Medical subject headings
Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vegetable proteins (VP) rich in leucine, cystein, arginineBehavioural

    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.

  • Animal proteins (AP)Behavioural

    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.

  • No protein (T)Behavioural

    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.

Study groups in NCT04923555
Study groupRoleWhat they receive
Group/Cohort1Experimental33 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
Receives: Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine; Behavioral: Animal proteins (AP); Behavioral: No protein (T)
Group/Cohort2Experimental33 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
Receives: Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine; Behavioral: Animal proteins (AP); Behavioral: No protein (T)
Group/Cohort3Placebo comparator33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt without any proteins (T) only once during the visit
Receives: Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine; Behavioral: Animal proteins (AP); Behavioral: No protein (T)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Day 0 (V1) at T-30min

  2. 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.

    Measured: Day 0 (V1) at T180min

  3. 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.

    Measured: Day 0 (V1) at T300min

  4. 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.

    Measured: Day 28 (V2) at T-30min

  5. 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.

    Measured: Day 28 (V2) at T180min

  6. 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.

    Measured: Day 28 (V2) at T300min

  7. 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.

    Measured: Day 56 (V3) at T-30min

  8. 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.

    Measured: Day 56 (V3) at T180min

  9. 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.

    Measured: Day 56 (V3) at T300min

Secondary outcomes (79)

  1. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  2. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  3. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  4. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  5. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  6. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  7. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  8. Plasma nitrite dosage

    Determination of nitrite plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  9. Urine nitrite dosage

    Determination of nitrite urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  10. Plasma nitrate dosage

    Determination of nitrate plasma concentration (µmol/L) (a biomarker of endothelial activation) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  11. Urine nitrate dosage

    Determination of nitrate urine concentration (µmol/L) (a biomarker of endothelial activation) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  12. Plasma creatinine dosage

    Determination of creatinine plasma concentration (µmol/L) (a biomarker of chronic kidney disease) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  13. Urine creatinine dosage

    Determination of creatinine urine concentration (µmol/L) (a biomarker of chronic kidney disease) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  14. Plasma malondialdehyde (MDA) dosage

    Determination of MDA plasma concentration (nmol/L) (a biomarker of oxidative stress) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  15. Urine malondialdehyde (MDA) dosage

    Determination of MDA urine concentration (nmol/L) (a biomarker of oxidative stress) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  16. Plasma asymmetric dimethylarginine (ADMA) dosage

    Determination of ADMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  17. Urine asymmetric dimethylarginine (ADMA) dosage

    Determination of ADMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  18. Plasma symmetric dimethylarginine (SDMA) dosage

    Determination of SDMA plasma concentration (µmol/L) (a biomarker of cardiovascular disease) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  19. Urine symmetric dimethylarginine (SDMA) dosage

    Determination of SDMA urine concentration (µmol/L) (a biomarker of cardiovascular disease) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  20. Plasma acetyl-lysine dosage

    Determination of acetyl-lysine plasma concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3)

  21. Urine symmetric acetyl-lysine dosage

    Determination of acetyl-lysine urine concentration (µmol/L) (a biomarker of vascular oxidative stress) between T-60min to T250min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  22. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  23. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  24. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  25. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  26. Plasma alanine dosage

    Determination of alanine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  27. Urine alanine dosage

    Determination of alanine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  28. Plasma arginine dosage

    Determination of arginine plasma concentration (µmol/L) between T-90min to T360min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  29. Urine arginine dosage

    Determination of arginine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  30. Plasma asparagine dosage

    Determination of asparagine plasma concentration (µmol/L) between T-90min to T360min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  31. Urine asparagine dosage

    Determination of asparagine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  32. Plasma aspartic acid dosage

    Determination of aspartic acid plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  33. Urine aspartic acid dosage

    Determination of aspartic acid urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  34. Plasma cysteine dosage

    Determination of cysteine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  35. Urine cysteine dosage

    Determination of cysteine urine concentration (µmol/L) between T-60min to T250min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  36. Plasma glutamic acid dosage

    Determination of glutamic acid plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  37. Urine glutamic acid dosage

    Determination of glutamic acid urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  38. Plasma glutamine dosage

    Determination of glutamine plasma concentration (µmol/L) between T-90min to T360min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  39. Urine glutamine dosage

    Determination of glutamine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  40. Plasma glycine dosage

    Determination of glycine plasma concentration (µmol/L) between T-90min to T360min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  41. Urine glycine dosage

    Determination of glycine urine concentration (µmol/L) between T-60min to T250min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  42. Plasma histidine dosage

    Determination of histidine plasma concentration (µmol/L) between T-90min to T360min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  43. Urine histidine dosage

    Determination of histidine urine concentration (µmol/L) between T-60min to T250min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  44. Plasma isoleucine dosage

    Determination of isoleucine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  45. Urine isoleucine dosage

    Determination of isoleucine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  46. Plasma leucine dosage

    Determination of leucine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  47. Urine leucine dosage

    Determination of leucine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  48. Plasma lysine dosage

    Determination of lysine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  49. Urine lysine dosage

    Determination of lysine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  50. Plasma methionine dosage

    Determination of methionine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  51. Urine methionine dosage

    Determination of methionine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  52. Plasma phenylalanine dosage

    Determination of phenylalanine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  53. Urine phenylalanine dosage

    Determination of phenylalanine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  54. Plasma proline dosage

    Determination of proline plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  55. Urine proline dosage

    Determination of proline urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  56. Plasma serine dosage

    Determination of serine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  57. Urine serine dosage

    Determination of serine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  58. Plasma threonine dosage

    Determination of threonine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  59. Urine threonine dosage

    Determination of threonine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  60. Plasma tryptophan dosage

    Determination of tryptophan plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  61. Urine tryptophan dosage

    Determination of tryptophan urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  62. Plasma tyrosine dosage

    Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  63. Urine tyrosine dosage

    Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  64. Plasma valine dosage

    Determination of tyrosine plasma concentration (µmol/L) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  65. Urine valine dosage

    Determination of tyrosine urine concentration (µmol/L) between T-60min to T250min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  66. 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

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  67. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  68. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  69. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  70. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  71. Plasma E-Selectine dosage

    Determination of E-Selectine plasma concentration (ng/ml) (a biomarker of endothelial activation) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  72. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  73. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  74. Plasma Glucose dosage

    Determination of glucose plasma concentration (mg/dl) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  75. Plasma triglycerides dosage

    Determination of triglycerides plasma concentration (mg/dl) between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  76. Plasma insulin dosage

    Determination of insulin plasma concentration (pmol/L) between T-90min to T360min

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  77. blood Peripheral Blood Mononuclear Cells (PBMC) count

    Determination of PBMC count (/mm3) and phenotyping between T-90min to T360min.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  78. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

  79. 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.

    Measured: Day 0 (V1), Day 28 (V2), Day 56 (V3).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2021
  2. Study start9 Nov 2021
  3. Primary completion7 Jun 2022
  4. Study completion7 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04923555
Sponsor's protocol ID
RBHP 2021 PICKERING
Other IDs
2021-A00134-37
Acronym
P-PROBS CM
Status last verified
Aug 2026
First submitted
1 Jun 2021
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Dimina LJ, Leray V, Voute M, David J, Blavignac C, Farges MC, Rossary A, Tsikas D, Remond D, Pickering G, Mariotti F. Dietary Protein in a Challenge Meal Does Not Alleviate Postprandial Impairments in Vascular Endothelial Function in Healthy Older Adults with Cardiometabolic Risk: A Randomized Crossover-Controlled Trial. J Nutr. 2024 Dec;154(12):3664-3680. doi: 10.1016/j.tjnut.2024.10.018. Epub 2024 Oct 16.

    PubMed 39424070

Questions about this trial

What is this clinical trial studying?

A study testing Vegetable proteins (VP) rich in leucine, cystein, arginine, Animal proteins (AP) and No protein (T) in people with Metabolic Syndrome and Predisposition to Cardiovascular Disease, run by University Hospital, Clermont-Ferrand at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brachial artery Flow Mediated Dilation (FMD) (time frame: Day 0 (V1) at T-30min). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04923555, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in