Therapeutic Fasting and Immune Aging

NCT05857241 | Not Yet Recruiting DMC

• 2 other identifiers: 21CH0282023-A00390-45
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

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.

Conditions

Fasting; Diet, Healthy

Keywords

Fasting mimicking diet; Aged; immunology; immunosenescence; tolerance

Outcome Measures

Primary Outcomes (1)

• 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).

  between Day 14 and Day 21

Secondary Outcomes (4)

• serious and non-serious adverse events reported

  Between day 0 to day 42

• composite outcome: evolution of biological biochemic parameters

  Day 0 to Day 42

• composite outcome: evolution of biological blood parameters

  Day 0 to Day 42

• composite outcome: evolution biological inflammatory parameters

  Day 0 to Day 42

Study Arms (1)

Fasting mimicking diet (FMD)

EXPERIMENTAL

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

Dietary Supplement: Fasting mimicking diet (FMD)

Interventions

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.

Fasting mimicking diet (FMD)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead

Study Sites (5)

EHPAD Claudinon

Le Chambon-Feugerolles, 42500, France

Location

EHPAD Les Cèdres Malataverne

Malataverne, 43200, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

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

Saint-Etienne, France

Location

EHPAD La M.R.L

Saint-Just-Saint-Rambert, 42170, France

Location

MeSH Terms

Conditions

Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Baptiste GRAMONT, MD

  Baptiste.Gramont@chu-st-etienne.fr

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Baptiste GRAMONT, MD

CONTACT

(0)0477829641; Baptiste.Gramont@chu-st-etienne.fr

Florence RANCON, CRA

CONTACT

florence.rancon@chu-st-etienne.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 12, 2023
• Study Start: April 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: April 8, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)