The Effect of a Fasting MimickINg Diet on the Immune System

NCT04833439 | Completed

• 2 other identifiers: NL76033.058.21P21.017
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Subjects; Cancer; Neoplasms

Keywords

Fasting; Caloric restriction; Immunomodulation; Tumor-Infiltrating Lymphocytes; Fasting Mimicking Diet

Outcome Measures

Primary Outcomes (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.

  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.

  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.

  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.

  4 weeks

• Percentage of participants reporting adverse events as assessed by CTCAE v5.0 during fasting mimicking diet

  8 weeks

Study Arms (1)

Fasting Mimicking Diet

EXPERIMENTAL

2 cycles of 3-day fasting mimicking spaced by a 2 week interval

Other: Fasting Mimicking Diet

Interventions

Fasting Mimicking Diet OTHER

Low-caloric, low-protein, plant-based diet regiment for 3 days

Also known as: Xentigen

Fasting Mimicking Diet

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Chronic disease or active infection
• A history of allergy

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (1)

Leiden University Medical Center

Leiden, South Holland, 2333 ZA, Netherlands

Location

MeSH Terms

Conditions

Neoplasms; Fasting

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Judith R Kroep

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: medical oncologist, associate professor

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: April 6, 2021
• Study Start: November 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 28, 2022
• Last Updated: July 27, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)