Analysis of the Postprandial Effects of a Vegetable Protein Mixture Rich in Arginine, Cysteine and Leucine on Endothelial Dysfunction and Inflammation at Low Noise in Elderly People With Cardiometabolic Risk (P-PROBS CM)

University Hospital, Clermont-Ferrand

Status: Completed

Conditions: Predisposition to Cardiovascular Disease; Metabolic Syndrome

Treatments: Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine; Behavioral: Animal proteins (AP); Behavioral: No protein (T)

Study type: Interventional

Funder types: Other

Identifiers

NCT04923555

RBHP 2021 PICKERING

2021-A00134-37 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 33 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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33 participants in 3 patient groups, including a placebo group

Group/Cohort1

Experimental group

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

Treatment:

Behavioral: No protein (T)

Behavioral: Animal proteins (AP)

Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine

Group/Cohort2

Experimental group

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

Treatment:

Behavioral: No protein (T)

Behavioral: Animal proteins (AP)

Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine

Group/Cohort3

Placebo Comparator group

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

Treatment:

Behavioral: No protein (T)

Behavioral: Animal proteins (AP)

Behavioral: Vegetable proteins (VP) rich in leucine, cystein, arginine