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NCT Number: NCT05857241

Therapeutic Fasting and Immune Aging

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.

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Key information

Conditions

Fasting Behavior Diet, Healthy Feeding Behavior

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

EHPAD Claudinon, Le Chambon-Feugerolles, France

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About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Primary outcomes

  1. rate of premature discontinuation of the fasting-mimicking diet

    Time frame: 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 outcomes

  1. serious and non-serious adverse events reported

    Time frame: 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)

  2. composite outcome: evolution of biological biochemic parameters

    Time frame: Day 0 to Day 42

    Evolution of measurements of blood glucose, ketones, albumin, prealbumin and IGF-1 Unit of measure : ng/ml

  3. composite outcome: evolution of biological blood parameters

    Time frame: 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 : %

  4. composite outcome: evolution biological inflammatory parameters

    Time frame: Day 0 to Day 42

    Evolution of inflammatory markers (CRP, IL1, IL6, TNFalpha) Unit of measure : ng/ml

Study contacts

Contact information is provided by the study sponsor or research team.

Baptiste GRAMONT, MD

CONTACT

[email protected]

(0)0477829641 ext. +33

Florence RANCON, CRA

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

Therapeutic Fasting and Immune Aging: A Pilot Study of Tolerance

Acronym: JÛVENILE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 12, 2023
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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