Clinical trial NCT04833439: The Effect of a Fasting MimickINg Diet on the Immune System
Official title: The Effect of a Fasting MimickINg Diet on the Immune System: an Exploratory Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Subjects
Cancer
Neoplasms
Keywords: Fasting
Caloric restriction
Immunomodulation
Tumor-Infiltrating Lymphocytes
Fasting Mimicking Diet
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
First posted: 2021-04-06
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.


Eligibility 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.

Primary outcomes:
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.
timeFrame: 4 weeks
Secondary outcomes:
measure: Change in immune cell properties from PBMCs after overnight fast and after 2 cycles of fasting mimicking diet compared to baseline.
timeFrame: 6 months
measure: 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.
timeFrame: 4 weeks
measure: Percentage of participants reporting adverse events as assessed by CTCAE v5.0 during fasting mimicking diet
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
state: Zuid-Holland
Study officials:
affiliation: Leiden University Medical Center
name: Judith R Kroep
role: PRINCIPAL_INVESTIGATOR
References: