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

Leiden University Medical Center (LUMC)

Status: Completed

Conditions: Neoplasms; Healthy Subjects; Cancer

Treatments: Other: Fasting Mimicking Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04833439

P21.017 (Other Identifier)

NL76033.058.21

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

16 participants in 1 patient group

Fasting Mimicking Diet

Experimental group

Description:

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

Treatment:

Other: Fasting Mimicking Diet