Therapeutic Fasting and Immune Aging: A Pilot Study of Tolerance
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 5
- 主要终点
- rate of premature discontinuation of the fasting-mimicking diet
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Fasting mimicking diet (FMD)
patients aged 65 and over, institutionalized in Long Term Care Units (USLD) or Establishments for the elderly (EHPAD).
干预措施: Fasting mimicking diet (FMD) (Dietary Supplement)
结局指标
主要结局
rate of premature discontinuation of the fasting-mimicking diet
时间窗: 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).
次要结局
- composite outcome: evolution of biological biochemic parameters(Day 0 to Day 42)
- composite outcome: evolution biological inflammatory parameters(Day 0 to Day 42)
- composite outcome: evolution of biological blood parameters(Day 0 to Day 42)
- serious and non-serious adverse events reported(Between day 0 to day 42)