FastingJÛVENILENCT05857241
Therapeutic Fasting and Immune Aging
A study testing Fasting mimicking diet (FMD) in people with Fasting and Diet, Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Fasting, Diet, Healthy
- What is being tested?
- Fasting mimicking diet (FMD)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesFrance
- Study dates
- Apr 2025to Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 11Show fewer
- 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).
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Florence RANCON, CRA contact
5 sites in 1 country
France5 sites
EHPAD Claudinon
Le Chambon-Feugerolles, 42500
Romain JUGAND, MD
Romain JUGAND, MD
EHPAD Les Cèdres Malataverne
Malataverne, 43200
Aurélie BUISSON, MD
Aurélie BUISSON
CHU de Saint-Etienne
Saint-Etienne, 42055
Baptiste GRAMONT, MD
Baptiste GRAMONT, MD
EHPAD de la Talaudière, la Rivière, la Croix de l'Horme
Saint-Etienne
Thomas CELARIER, PhD
Thomas CELARIER
EHPAD La M.R.L
Saint-Just-Saint-Rambert, 42170
Anne PAVY, MD
Anne PAVY, MD
About this study
Official title: Therapeutic Fasting and Immune Aging: A Pilot Study of Tolerance
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.
Read the 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
- Being tested
- Fasting mimicking diet (FMD)
- Keywords
- Fasting mimicking diet, Aged, immunology, immunosenescence, tolerance
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting mimicking diet (FMD) | Experimental | patients aged 65 and over, institutionalized in Long Term Care Units (USLD) or Establishments for the elderly (EHPAD). Receives: Dietary Supplement: Fasting mimicking diet (FMD) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: between Day 14 and Day 21
Secondary outcomes (4)
serious and non-serious adverse events reported
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)
Measured: Between day 0 to day 42
composite outcome: evolution of biological biochemic parameters
Evolution of measurements of blood glucose, ketones, albumin, prealbumin and IGF-1 Unit of measure : ng/ml
Measured: Day 0 to Day 42
composite outcome: evolution of biological blood parameters
Evolution of the measurement of the blood total lymphocyte count (CD4, CD8, CD19, naive, effectors, memories, regulators, etc.).
Unit of measure : %
Measured: Day 0 to Day 42
composite outcome: evolution biological inflammatory parameters
Evolution of inflammatory markers (CRP, IL1, IL6, TNFalpha) Unit of measure : ng/ml
Measured: Day 0 to Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2023
- Study startApr 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baptiste GRAMONT, MD, Principal investigator, Baptiste.Gramont@chu-st-etienne.fr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05857241
- Sponsor's protocol ID
- 21CH028
- Other IDs
- 2023-A00390-45
- Acronym
- JÛVENILE
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2023
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Fasting and Immune Aging: A Pilot Study of Tolerance
- ClinicalTrials.gov ID
- NCT05857241
- Acronym / sponsor ID
- JÛVENILE / 21CH028
- Conditions
- Fasting, Diet, Healthy
- Keywords
- Fasting mimicking diet, Aged, immunology, immunosenescence, tolerance
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 12 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting mimicking diet (FMD) | Experimental | Dietary Supplement: Fasting mimicking diet (FMD)patients aged 65 and over, institutionalized in Long Term Care Units (USLD) or Establishments for the elderly (EHPAD). |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Fasting mimicking diet (FMD) |
Primary outcome
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).
4 secondary outcomes
serious and non-serious adverse events reported
Time frame: Between day 0 to day 42
composite outcome: evolution of biological biochemic parameters
Time frame: Day 0 to Day 42
composite outcome: evolution of biological blood parameters
Time frame: Day 0 to Day 42
composite outcome: evolution biological inflammatory parameters
Time frame: Day 0 to Day 42
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Florence RANCON, CRA contact
Baptiste GRAMONT, MD principal investigator
Baptiste.Gramont@chu-st-etienne.fr
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting mimicking diet (FMD) in people with Fasting and Diet, Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Baptiste GRAMONT, MD ((0)0477829641 ext. +33, Baptiste.Gramont@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of premature discontinuation of the fasting-mimicking diet (time frame: between Day 14 and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2025.