Healthy SubjectsFINDNCT04833439
The Effect of a Fasting MimickINg Diet on the Immune System
A study testing Fasting Mimicking Diet in people with Healthy Subjects and Cancer, run by Leiden University Medical Center at 1 site in Netherlands.
Trial summary
Fasting or a Fasting Mimicking diet (FMD) can lower blood concentration of glucose and IGF1. Since cancer cells rely mostly on a glucose-based metabolism, FMD renders cancer cells more vulnerable to chemotherapy, thereby enhancing therapeutic efficacy. This process is known as differential stress sensitization (DSS). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects, Cancer, Neoplasms
- What is being tested?
- Fasting Mimicking Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2021to 28 Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 years old
- BMI ≥18.5 and ≤25kg/m2
Who cannot join
- Chronic disease or active infection
- Medication use other than contraceptive, during the last 12 weeks prior to inclusion.
- A history of allergy
- Blood or plasma donation in the last 12 weeks prior to inclusion.
- Participation in other medical research in the last 12 weeks prior to inclusion.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Leiden University Medical Center
Leiden, South Holland, 2333 ZA
About this study
Official title: The Effect of a Fasting MimickINg Diet on the Immune System: an Exploratory Study
Fasting or a Fasting Mimicking diet (FMD) can lower blood concentration of glucose and IGF1. Since cancer cells rely mostly on a glucose-based metabolism, FMD renders cancer cells more vulnerable to chemotherapy, thereby enhancing therapeutic efficacy. This process is known as differential stress sensitization (DSS). Another response to nutritional stress by fasting is known as differential stress resistance (DSR). DSR is a state in which healthy cells rather focus resources on protection and internal repair, which can result in reduced chemotherapeutic toxicity. Recent preclinical studies found that fasting or FMD not only aids healthy cell protection, but also has the potential to benefit effector T-cells and could thereby improve antitumor immunity. However in most oncotherapeutic clinical trials investigating the addition of a fasting regimen, other factors such as chemotherapy, surgery and additional medication affect the immune system as well. That is why this explorative study, conducted in healthy subjects, might be more suitable to investigate the immunological alterations upon FMD more specifically. This exploratory study aims to identify immunological alterations by using extensive immunoprofiling before and after three days of FMD in healthy subjects, as well as investigate possible side effects of FMD.
- Conditions
- Healthy Subjects, Cancer, Neoplasms
- Being tested
- Fasting Mimicking Diet
- Keywords
- Fasting, Caloric restriction, Immunomodulation, Tumor-Infiltrating Lymphocytes, Fasting Mimicking Diet
- Medical subject headings
- Neoplasms, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fasting Mimicking DietOther
Also called Xentigen
Low-caloric, low-protein, plant-based diet regiment for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Fasting Mimicking Diet | Experimental | 2 cycles of 3-day fasting mimicking spaced by a 2 week interval Receives: Other: Fasting Mimicking Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gene expression signature in peripheral blood mononuclear cells (PBMCs) after overnight fast and after completion of 2 cycles of fasting mimicking diet compared to baseline.
PBMCs are retrieved from whole blood samples. Gene expression signature is retrieved from PBMCs using RNA-Nanostring technique with the Pancancer IO 360 panel. The Nanostring will report RNA counts for a panel of 770 genes, including 40 housekeeping genes. The data will be normalized on the 40 housekeeping genes for internal control using Nanostring nSolver software. The fold change from baseline to overnight fast and after completion of second fasting mimicking diet will provide insight in affected pathways as well as metabolic and immune signatures.
Measured: 4 weeks
Secondary outcomes (3)
Change in immune cell properties from PBMCs after overnight fast and after 2 cycles of fasting mimicking diet compared to baseline.
PBMCs retrieved from whole blood samples will be analysed with a 40-plex Aurora flowcytometry panel with markers for T cells and myeloid cells. The flow cytometry will generate frequencies of the different immune cell markers,. A comparison of the frequency data between blood samples will determine change in immune cell properties.
This analysis will be used to confirm and complement gene expression signature findings on a protein level.
Measured: 6 months
Change in plasma concentration of IGF1, glucose and ketone bodies (Beta-hydroxybutyric acid) after overnight fast and after completion of 2 cycles of fasting mimicking diet compared to baseline.
Measured in blood plasma taken at 3 time points.
Measured: 4 weeks
Percentage of participants reporting adverse events as assessed by CTCAE v5.0 during fasting mimicking diet
Descriptive analysis of adverse events by type and grade according to NCI CTCAE v5.0 experienced by participants during fasting mimicking diet assessed after second cycle on day 22.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start1 Nov 2021
- Primary completion1 Apr 2022
- Study completion28 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies of the same condition, open and under way.
- More trials run by Leiden University Medical CenterThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leiden University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J.R. Kroep, Leiden University Medical Center
- Investigators
- Judith R Kroep, Principal investigator, Leiden University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833439
- Sponsor's protocol ID
- NL76033.058.21
- Other IDs
- P21.017
- Acronym
- FIND
- Status last verified
- Jul 2022
- First submitted
- 30 Mar 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Fasting MimickINg Diet on the Immune System: an Exploratory Study
- ClinicalTrials.gov ID
- NCT04833439
- Acronym / sponsor ID
- FIND / NL76033.058.21
- Conditions
- Healthy Subjects, Cancer, Neoplasms
- Keywords
- Fasting, Caloric restriction, Immunomodulation, Tumor-Infiltrating Lymphocytes, Fasting Mimicking Diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Leiden University Medical CenterUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 28 Apr 2022 (actual)
- First posted
- 6 Apr 2021 (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.
Fasting or a Fasting Mimicking diet (FMD) can lower blood concentration of glucose and IGF1. Since cancer cells rely mostly on a glucose-based metabolism, FMD renders cancer cells more vulnerable to chemotherapy, thereby enhancing therapeutic efficacy. This process is known as differential stress sensitization (DSS). Another response to nutritional stress by fasting is known as differential stress resistance (DSR). DSR is a state in which healthy cells rather focus resources on protection and internal repair, which can result in reduced chemotherapeutic toxicity. Recent preclinical studies found that fasting or FMD not only aids healthy cell protection, but also has the potential to benefit effector T-cells and could thereby improve antitumor immunity. However in most oncotherapeutic clinical trials investigating the addition of a fasting regimen, other factors such as chemotherapy, surgery and additional medication affect the immune system as well. That is why this explorative study, conducted in healthy subjects, might be more suitable to investigate the immunological alterations upon FMD more specifically. This exploratory study aims to identify immunological alterations by using extensive immunoprofiling before and after three days of FMD in healthy subjects, as well as investigate possible side effects of FMD.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting Mimicking Diet | Experimental | Other: Fasting Mimicking Diet2 cycles of 3-day fasting mimicking spaced by a 2 week interval |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ≥18 years old
- BMI ≥18.5 and ≤25kg/m2
Key exclusion criteria (5 listed)
- Chronic disease or active infection
- Medication use other than contraceptive, during the last 12 weeks prior to inclusion.
- A history of allergy
- Blood or plasma donation in the last 12 weeks prior to inclusion.
- Participation in other medical research in the last 12 weeks prior to inclusion.
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 DietAlso: XentigenLow-caloric, low-protein, plant-based diet regiment for 3 days | Other | Fasting Mimicking Diet |
Primary outcome
Change in gene expression signature in peripheral blood mononuclear cells (PBMCs) after overnight fast and after completion of 2 cycles of fasting mimicking diet compared to baseline.
Time frame: 4 weeks
PBMCs are retrieved from whole blood samples. Gene expression signature is retrieved from PBMCs using RNA-Nanostring technique with the Pancancer IO 360 panel. The Nanostring will report RNA counts for a panel of 770 genes, including 40 housekeeping genes. The data will be normalized on the 40 housekeeping genes for internal control using Nanostring nSolver software. The fold change from baseline to overnight fast and after completion of second fasting mimicking diet will provide insight in affected pathways as well as metabolic and immune signatures.
3 secondary outcomes
Change in immune cell properties from PBMCs after overnight fast and after 2 cycles of fasting mimicking diet compared to baseline.
Time frame: 6 months
Change in plasma concentration of IGF1, glucose and ketone bodies (Beta-hydroxybutyric acid) after overnight fast and after completion of 2 cycles of fasting mimicking diet compared to baseline.
Time frame: 4 weeks
Percentage of participants reporting adverse events as assessed by CTCAE v5.0 during fasting mimicking diet
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
- 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. This study is not recruiting at the moment.
Judith R Kroep principal investigator
Leiden University Medical Center
1 site 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 in people with Healthy Subjects and Cancer, run by Leiden University Medical Center at 1 site in Netherlands.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in gene expression signature in peripheral blood mononuclear cells (PBMCs) after overnight fast and after completion of 2 cycles of fasting mimicking diet compared to baseline. (time frame: 4 weeks). 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 27 Jul 2022.