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
2 other identifiers
interventional
33
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 1, 2021
CompletedFirst Posted
Study publicly available on registry
June 11, 2021
CompletedStudy Start
First participant enrolled
November 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2022
CompletedJune 13, 2022
June 1, 2022
7 months
June 1, 2021
June 10, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
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.
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.
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.
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.
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.
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.
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.
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.
Day 56 (V3) at T300min
Secondary Outcomes (79)
Rest flow by Flowmetry Laser Doppler (FLD)
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Occlusion area by FLD
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Hyperaemia area by FLD
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Hyperaemia area / occlusion area ratio by FLD
Day 0 (V1), Day 28 (V2), Day 56 (V3)
Maximal flow by FLD
Day 0 (V1), Day 28 (V2), Day 56 (V3)
- +74 more secondary outcomes
Study Arms (3)
Group/Cohort1
EXPERIMENTAL33 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/Cohort2
EXPERIMENTAL33 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/Cohort3
PLACEBO 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- Man or woman
- 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
You may not qualify if:
- 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
- Allergies to any of the components of the test meals
- Alcohol consumption\> 2 glasses / day
- Current smokers (\> 6 cigarettes per week)
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU clermont-ferrand
Clermont-Ferrand, France
Related Publications (1)
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.
PMID: 39424070DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gisèle PICKERING
University Hospital, Clermont-Ferrand
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- 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.
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2021
First Posted
June 11, 2021
Study Start
November 9, 2021
Primary Completion
June 7, 2022
Study Completion
June 7, 2022
Last Updated
June 13, 2022
Record last verified: 2022-06