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

NCT ID: NCT04923555

Last Updated: 2022-06-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-09
• Study Completion Date: 2022-06-07

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.

Conditions

Metabolic Syndrome; Predisposition to Cardiovascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: QUADRUPLE

Study Groups

Group/Cohort1

33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in cysteine, leucine and arginine (VP, vegetable proteins) only once during the visit

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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.

Group/Cohort2

33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt rich in animal proteins (AP) only once during the visit

Group Type: EXPERIMENTAL

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

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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.

Group/Cohort3

33 subjects aged 65 years old with predisposition to cardiometabolic syndrome will consume 400ml of yogurt without any proteins (T) only once during the visit

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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)

Intervention Type: BEHAVIORAL

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.

Interventions

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

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

Animal proteins (AP)

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

No protein (T)

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Clermont-Ferrand

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gisèle PICKERING

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

CHU clermont-ferrand

Clermont-Ferrand, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 39424070 (View on PubMed)

Other Identifiers

2021-A00134-37

Identifier Type: OTHER

Identifier Source: secondary_id

RBHP 2021 PICKERING

Identifier Type: -

Identifier Source: org_study_id