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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-A00390-45 | Other Identifier | ANSM |
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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.
In order to fight against immunosenescence, many therapeutics are envisaged, with the aim of restoring, renewing and/or reprogramming the immune system. Among these leads, therapeutic fasting, and in particular the "fasting mimicking diet" (FMD), seems to modify the reprogramming and renewal of the immune system with, on the one hand, the elimination of inefficient "overactivated" cells and, on the other hand, the activation of hematopoietic stem cells. FMD consists of a significant reduction in food intake, limited to 3-5 days/month. The FMD seems to be the best compromise between efficacy and tolerance (already evaluated in humans, including oncology).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fasting mimicking diet (FMD) | Experimental | patients aged 65 and over, institutionalized in Long Term Care Units (USLD) or Establishments for the elderly (EHPAD). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fasting mimicking diet (FMD) | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| rate of premature discontinuation of the fasting-mimicking diet | 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:
| between Day 14 and Day 21 |
| Measure | Description | Time Frame |
|---|---|---|
| serious and non-serious adverse events reported | Comparison of the nature and frequency of serious and non-serious adverse events reported from D0 to D13 (pre fasting diet phase), D14 to D16 (fasting diet phase) and D17 to D42 (post fasting diet phase) | Between day 0 to day 42 |
| composite outcome: evolution of biological biochemic parameters |
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Inclusion Criteria :
Exclusion Criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Baptiste GRAMONT, MD | Contact | (0)0477829641 | +33 | Baptiste.Gramont@chu-st-etienne.fr |
| Florence RANCON, CRA | Contact | florence.rancon@chu-st-etienne.fr |
| Name | Affiliation | Role |
|---|---|---|
| Baptiste GRAMONT, MD | Baptiste.Gramont@chu-st-etienne.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| EHPAD Claudinon | Le Chambon-Feugerolles | 42500 | France |
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| ID | Term |
|---|---|
| D005215 | Fasting |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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Evolution of measurements of blood glucose, ketones, albumin, prealbumin and IGF-1 Unit of measure : ng/ml |
| Day 0 to Day 42 |
| composite outcome: evolution of biological blood parameters | Evolution of the measurement of the blood total lymphocyte count (CD4, CD8, CD19, naive, effectors, memories, regulators, etc.). Unit of measure : % | Day 0 to Day 42 |
| composite outcome: evolution biological inflammatory parameters | Evolution of inflammatory markers (CRP, IL1, IL6, TNFalpha) Unit of measure : ng/ml | Day 0 to Day 42 |
| EHPAD Les Cèdres Malataverne | Malataverne | 43200 | France |
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| CHU de Saint-Etienne | Saint-Etienne | 42055 | France |
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| EHPAD de la Talaudière, la Rivière, la Croix de l'Horme | Saint-Etienne | France |
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| EHPAD La M.R.L | Saint-Just-Saint-Rambert | 42170 | France |
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