Fasting mimicking diet (FMD): D1 will correspond to a "pre-fasting" phase, with about 800 kcal of intake (approximately 40% of normal caloric intake) from a mono-nutrient diet (fruit, rice or potato according to the patient's preferences). Then D2 and D3 will correspond to the days of actual fasting, with 200-350 kcal of intake (10-18% of normal caloric intake) in the form of 100 ml of broth or vegetable juice (with a teaspoon of linseed oil) three times a day, and vaccination will take place on D4, after returning to a normal diet. 2 to 3 liter of water or unsweetened drink per day is required.Laxatives (unsweetened) will be prescribed and can be taken as during the fasting period.
Study summary
Immunosenescence is the age-related decline of the immune system, involving a state of chronic inflammation and a decrease in the diversity/adaptability of the lymphocyte repertoire. The consequences of immunosenescence are multiple, including increased susceptibility to infections and poorer vaccine responses.
Eligibility
Sex
ALL
Min age
65 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria :
* Patient affiliated or entitled to a social security scheme
* Residing in a Long-Term Care Unit (LTCU) or a Facility for the Elderly Dependent (EHPAD)
* A person deemed a priori, by the geriatrician member of the monitoring committee, to be capable of following the dietary recommendations required for the study.
* A person deemed a priori, by the clinician in charge, to be able to follow the dietary recommendations required by the study.
* Patient who has received informed information about the study and has co-signed a consent to participate in the study with the investigator.
Exclusion Criteria :
* Inability and/or unwillingness to follow dietary recommendations and/or perform follow-up examinations required for the study
* Iso-resource group 1 or 2 according to the AGGIR grid
* BMI \< 18.5 kg/m2 or recent weight loss \> 5% in 1 month or recent weight loss \> 10% in 6 months from previous weight
* Albuminemia \< 30g/l
* All swallowing disorders requiring a specific diet.
* Influenza vaccination received prior to inclusion
* Episode of influenza or suspected influenza during the 2020-2021 season and prior to inclusion
* Any acute medical or surgical event less than 2 weeks prior to inclusion
* Presence of systemic inflammatory or autoimmune disease
* Presence of an innate or acquired immune deficiency (including taking immunosuppressive treatment)
* Presence of a chronic disease which, according to the physician, makes the follow-up of a "fasting diet" and/or the consumption of large amounts of liquids (cf. fasting diet modalities) risky (e.g. insulin-dependent or insulin-requiring diabetes, severe heart failure, severe kidney failure, active cancer, significant undernutrition...) or impossible (e.g. advanced neurodegenerative pathology).
Primary outcome measure(s)
rate of premature discontinuation of the fasting-mimicking diet — between Day 14 and Day 21 measurement of the rate of occurrence of a clinical event considered to require discontinuation of the fasting diet :
The occurrence of a clinical event considered to require discontinuation of the fasting diet will be defined as the presence between D14 and D21 of at least one of the following conditions:
* Weight loss \> 5%,
* Hypoglycemia \< 0.5 g/l (\< 2.8 mmol/l),
* Hypothermia \< 35°C,
* Heart rate \< 50 beats per minute, checked twice at 15 minute intervals,
* Low systolic blood pressure \< 90 mmHg or \> 200 mmHg; or diastolic blood pressure \< 60 mmHg or \> 110 mmHg; or mean blood pressure \< 70 mmHg, checked twice at 15-minute intervals,
* Increase of 5 points on the visual analog pain scale between D14 and D21,
* A score of 1 on the EVIBE visual analog scale (instantaneous assessment of well-being) between D14 and D21,
* Any serious acute clinical event (fall with serious traumatic consequence, acute medical or surgical condition).
Trial sites (5)
Facility
City
Region
Status
EHPAD Claudinon
Le Chambon-Feugerolles
France
EHPAD Les Cèdres Malataverne
Malataverne
France
CHU de Saint-Etienne
Saint-Etienne
France
EHPAD de la Talaudière, la Rivière, la Croix de l'Horme
Saint-Etienne
France
EHPAD La M.R.L
Saint-Just-Saint-Rambert
France
More Centre Hospitalier Universitaire de Saint Etienne trials in France
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.
