Therapeutic Fasting and Immune Aging

Официальное название

Therapeutic Fasting and Immune Aging: A Pilot Study of Tolerance

Обзор

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.

Подробное описание

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).

Вмешательства

• Пищевая добавка 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 norm

Первичные конечные точки

• rate of premature discontinuation of the fasting-mimicking diet [Срок оценки: between Day 14 and Day 21]

Вторичные конечные точки (4)

• serious and non-serious adverse events reported [Срок оценки: Between day 0 to day 42]
• composite outcome: evolution of biological biochemic parameters [Срок оценки: Day 0 to Day 42]
• composite outcome: evolution of biological blood parameters [Срок оценки: Day 0 to Day 42]
• composite outcome: evolution biological inflammatory parameters [Срок оценки: Day 0 to Day 42]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 5 центров

• EHPAD Claudinon — Le Chambon-Feugerolles
• EHPAD Les Cèdres Malataverne — Malataverne
• CHU de Saint-Etienne — Saint-Etienne
• EHPAD de la Talaudière, la Rivière, la Croix de l'Horme — Saint-Etienne
• EHPAD La M.R.L — Saint-Just-Saint-Rambert

Идентификаторы

NCT: NCT05857241 · 21CH028 · 2023-A00390-45

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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