To contribute to the evaluation of 'fasting mimicking diet' application in oncotherapeutic setting and to gain insight on the underlying mechanisms in response to a fasting mimicking diet. This explorative study focuses on the immune…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde proefpersonen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The changes in gene expression profile and pathway signaling in white blood
cells using RNA nanostring analysis on whole blood samples. The blood samples
are collected at 3 different time points in a fed state, fasted state and after
the second cycle of the fasting mimicking diet.
Secondary outcome
- Flow cytometry on peripheral blood mononuclear cells, including confirmation
of gene expression profile alterations on the protein level.
- Change in plasma concentration of IGF1, glucose and ketone bodies.
- Evaluation of experienced side effects from FMD recorded in the toxicity
forms in the Case report form (CRF) assessed on day 1 and 31.
Background summary
A preclinical stuy by Di Biase et al (2016), showed that short-term fasting
protects tumor-bearing mice against the toxic effects of chemotherapy, improves
the CD8+ T cell intratumour infiltration, while enhancing the chemotherapy
efficacy. This preclinical research suggests that fasting potentially has a
beneficial effect on effector T-cells of the immune system, which could aid
antitumorimmunity. However the effect of fasting on the immune system in humans
is still largely unknown, especially in an oncotherapeutic setting.
The DIRECT-study (DIetary REstriction as an adjunct to neoadjuvant ChemoTherapy
for HER2 negative breast cancer) examined the effects of six neoadjuvant
chemotherapy cycles with or without peri-chemotherapeutic fasting mimicking
diet and investigated the therapeutic efficacy and toxicity.
In this explorative study the effect of a fasting mimicking diet on the immune
cells and -response will be investigated in healthy volunteers. This will
provide direction for translational experiments in future clinical trials.
Study objective
To contribute to the evaluation of 'fasting mimicking diet' application in
oncotherapeutic setting and to gain insight on the underlying mechanisms in
response to a fasting mimicking diet. This explorative study focuses on the
immune system and -response after two cycli of a four day fasting mimicking
diet. Performing this explorative study will provide direction regarding what
change in which type of immune cells can be observed. These findings will aid
in the setup and interpretation of future translational experiments in the
context of clinical studies building on the DIRECT study.
Study design
Observational research
Study burden and risks
Participation requires the healthy volunteers to adhere to 2 cycles of 4-day
FMD provided by the LUMC. Participants could experience transient mild symptoms
like headache, dizziness, fatigue and feeling hungry during FMD, due to
consuming less calories. Another possible minimal risk is pain and hematoma
during and/or after blood collection. The blood samples of 7 tubes (43,5ml
total) will be taken at three time points. In addition the participants will
fill out a toxicity questionnaire concerning any experienced side effects on
day 31. The appointments require three visits, each less than 30 minutes.
Albinusdreef 2
LEIDEN 2333 ZA
NL
Albinusdreef 2
LEIDEN 2333 ZA
NL
Listed location countries
Age
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.
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
| Register | ID |
|---|---|
| CCMO | NL76033.058.21 |