An interventional study of Fasting mimicking diet (FMD) in Fasting and Diet, Healthy, sponsored by Centre Hospitalier Universitaire de Saint Etienne. Not yet recruiting at 5 sites in France. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.
Sponsored by Centre Hospitalier Universitaire de Saint Etienne · Not applicable, Interventional, and Treatment
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).
Centre Hospitalier Universitaire de Saint Etienne is the lead sponsor of 578 studies on the registry; 128 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria :
patients aged 65 and over, institutionalized in Long Term Care Units (USLD) or Establishments for the elderly (EHPAD).
Dietary Supplement: 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.
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: * 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).
Time frame: between Day 14 and Day 21
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)
Time frame: Between day 0 to day 42
composite outcome: evolution of biological biochemic parameters
Evolution of measurements of blood glucose, ketones, albumin, prealbumin and IGF-1 Unit of measure : ng/ml
Time frame: 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 : %
Time frame: Day 0 to Day 42
composite outcome: evolution biological inflammatory parameters
Evolution of inflammatory markers (CRP, IL1, IL6, TNFalpha) Unit of measure : ng/ml
Time frame: Day 0 to Day 42
Plan to share: No
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This study is not yet recruiting, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier Universitaire de Saint Etienne