Therapeutic Fasting and Immune Aging

NCT ID: NCT05857241

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-30
• Study Completion Date: 2026-03-31

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).

Conditions

Fasting; Diet, Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Fasting mimicking diet (FMD)

patients aged 65 and over, institutionalized in Long Term Care Units (USLD) or Establishments for the elderly (EHPAD).

Group Type: EXPERIMENTAL

Fasting mimicking diet (FMD)

Intervention Type: 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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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).

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Baptiste GRAMONT, MD

Role: PRINCIPAL_INVESTIGATOR

Baptiste.Gramont@chu-st-etienne.fr

Locations

EHPAD Claudinon

Le Chambon-Feugerolles, , France

EHPAD Les Cèdres Malataverne

Malataverne, , France

CHU de Saint-Etienne

Saint-Etienne, , France

EHPAD de la Talaudière, la Rivière, la Croix de l'Horme

Saint-Etienne, , France

EHPAD La M.R.L

Saint-Just-Saint-Rambert, , France

Countries

France

Central Contacts

Baptiste GRAMONT, MD

Role: CONTACT

Baptiste.Gramont@chu-st-etienne.fr

(0)0477829641 ext. +33

Florence RANCON, CRA

Role: CONTACT

florence.rancon@chu-st-etienne.fr

Facility Contacts

Romain JUGAND, MD

Role: primary

Aurélie BUISSON, MD

Role: primary

Baptiste GRAMONT, MD

Role: primary

Thomas CELARIER, PhD

Role: primary

Anne PAVY, MD

Role: primary

Other Identifiers

2023-A00390-45

Identifier Type: OTHER

Identifier Source: secondary_id

21CH028

Identifier Type: -

Identifier Source: org_study_id