Therapeutic Fasting and Immune Aging
- Conditions
- Diet, HealthyFasting
- Interventions
- Dietary Supplement: Fasting mimicking diet (FMD)
- Registration Number
- NCT05857241
- Brief 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.
- Detailed Description
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).
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Fasting mimicking diet (FMD) Fasting mimicking diet (FMD) patients aged 65 and over, institutionalized in Long Term Care Units (USLD) or Establishments for the elderly (EHPAD).
- Primary Outcome Measures
Name Time Method 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).
- Secondary Outcome Measures
Name Time Method composite outcome: evolution of biological biochemic parameters Day 0 to Day 42 Evolution of measurements of blood glucose, ketones, albumin, prealbumin and IGF-1 Unit of measure : ng/ml
composite outcome: evolution biological inflammatory parameters Day 0 to Day 42 Evolution of inflammatory markers (CRP, IL1, IL6, TNFalpha) Unit of measure : ng/ml
composite outcome: evolution of biological blood parameters Day 0 to Day 42 Evolution of the measurement of the blood total lymphocyte count (CD4, CD8, CD19, naive, effectors, memories, regulators, etc.).
Unit of measure : %serious and non-serious adverse events reported Between day 0 to day 42 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)
Trial Locations
- Locations (5)
EHPAD Claudinon
🇫🇷Le Chambon-Feugerolles, France
CHU de Saint-Etienne
🇫🇷Saint-Etienne, France
EHPAD Les Cèdres Malataverne
🇫🇷Malataverne, France
EHPAD La M.R.L
🇫🇷Saint-Just-Saint-Rambert, France
EHPAD de la Talaudière, la Rivière, la Croix de l'Horme
🇫🇷Saint-Étienne, France