Analysis of the Postprandial Effects of a Vegetable Protein Mixture Rich in Arginine, Cysteine an… (NCT04923555) | Clinical Trial Compass
CompletedNot Applicable
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
France33 participantsStarted 2021-11-09
Plain-language 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.
Who can participate
Age range
65 Years
Sex
ALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.