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The Effect of a Fasting MimickINg Diet on the Immune System (FIND)

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ClinicalTrials.gov Identifier: NCT04833439
Recruitment Status : Not yet recruiting
First Posted : April 6, 2021
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
J.R. Kroep, Leiden University Medical Center

Study Description
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Brief 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). 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.

Condition or disease Intervention/treatment Phase
Healthy Subjects Cancer Neoplasms Other: Fasting Mimicking Diet Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Effect of a Fasting MimickINg Diet on the Immune System: an Exploratory Study
Estimated Study Start Date : April 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Fasting Mimicking Diet
2 cycles of 3-day fasting mimicking spaced by a 2 week interval
 Other: Fasting Mimicking Diet
Low-caloric, low-protein, plant-based diet regiment for 3 days
Other Name: Xentigen


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]

    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.


  2. 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 ]
    Measured in blood plasma taken at 3 time points.

  3. Percentage of participants reporting adverse events as assessed by CTCAE v5.0 during fasting mimicking diet [ Time Frame: 8 weeks ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ≥18 years old
  • BMI ≥18.5 and ≤25kg/m2

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04833439


Contacts
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Contact: Judith R Kroep +3171-5263464 J.R.kroep@lumc.nl
Contact: Nadia de Gruil N.de_gruil@lumc.nl

Sponsors and Collaborators
Leiden University Medical Center
Investigators
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Principal Investigator: Judith R Kroep Leiden University Medical Center
More Information
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Responsible Party: J.R. Kroep, medical oncologist, associate professor, Leiden University Medical Center
ClinicalTrials.gov Identifier: NCT04833439    
Other Study ID Numbers: NL76033.058.21
P21.017 ( Other Identifier: LUMC )
First Posted: April 6, 2021    Key Record Dates
Last Update Posted: April 8, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by J.R. Kroep, Leiden University Medical Center:
Fasting
Caloric restriction
Immunomodulation
Tumor-Infiltrating Lymphocytes
Fasting Mimicking Diet