The Meta-SHIFT Study: How Metabolic Shift Shapes Human Immunometabolism - a Fasting Trial

ConditionFasting

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-40

SponsorCornell University

About this trial

During fasting, the body shifts from using carbohydrates to relying more on fat as its main source of energy. This process is known as the 'metabolic shift'. Fat tissue helps supply this energy by breaking down stored fat into fatty acids, which are released into the bloodstream and transported to organs throughout the body. In addition to fatty acids, many other substances in the blood (such as metabolites) change during fasting to help maintain normal body function.

Immune cells also circulate in the blood and play an important role in protecting the body against infections and diseases such as cancer. However, it is not yet well understood how the metabolic shift during fasting affects immune cell function. The purpose of this study is to investigate how 24 hours of fasting influences immune cell metabolism and function.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Apparently healthy

Age 18-40y at the time of recruitment

BMI ≥ 18.5 and ≤ 24.9 kg/m2

Willing to participate in all study activities during the 3-day intervention

Disqualifiers

Diagnosed with any chronic medical condition that can interfere with the study outcome (e.g., cardiovascular disease, cancer, diabetes mellitus type 1 or 2, liver disease, pulmonary disease, renal disease, inflammatory bowel disease, thyroid disease, long COVID, PASC)

Bleeding disorder (e.g., Hemophilia A/B, Von Willebrand Disease, or low platelets), current anemia or current use of blood thinners or anticoagulants (e.g. warfarin, heparin)

Any acute or chronic infection disease or fever in the past month

Antibiotic use in the past 2 months

Trial design

Design model

Single group

Treatments tested in this trial

Fasting
Other intervention
After consumption of a standardized breakfast (energy content adjusted to individual BMR), participants will undergo a 26-hour fast (water only), followed by consumption of a second standardized breakfast.

Treatment groups

28 Participants

are divided into 1 treatment group

Group A: FastingExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in PBMC energy metabolism.

Change from baseline PBMC glucose dependence (%) and mitochondrial dependence (%) at 24-hours, as measured by the flow cytometry-based CENCAT method.

Time frame

Baseline, 24 hours

Change in activated PBMC energy metabolism.

Change from baseline activated PBMC glucose dependence (%) and mitochondrial dependence (%) at 24-hours, as measured by the flow cytometry-based CENCAT method. PBMCs are activated in vitro for 2-hours using LPS or TransAct.

Time frame

Baseline, 24 hours

Change in inflammatory capacity of activated PBMCs.

Change from baseline activated PBMC cytokine positive cells (%) and relative cellular cytokine quantity (fluorescent intensity) at 24-hours, as measured by a flow cytometry-based intracellular cytokine stain. PBMCs are activated in vitro for 2-hours using LPS or TransAct.

Time frame

Baseline, 24 hours

Change in PBMC subset abundance.

Change from baseline PBMC subset counts, as assessed with a hematology analyzer.

Time frame

Baseline, 24 hours

Secondary outcomes

Change in PBMC transcriptome.

Change from baseline whole genome single cell RNA expression in PBMCs at 24 hours.

Time frame

Baseline, 24 hours

Change in plasma metabolite profile.

Change from baseline plasma metabolite levels at 24 hours.

Time frame

Baseline, 24 hours

Change in PBMC RNA expression.

Change from baseline and 24-hour RNA expression of identified fasting target genes in PBMCs at 26 hours.

Time frame

Baseline, 24 hours, 26 hours

Other outcomes

Change in subcutaneous adipose tissue immune cell transcriptome.

Change from baseline whole genome single cell RNA expression in subcutaneous adipose tissue immune cells at 24 hours.

Time frame

Baseline, 24 hours

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cornell University

Lead sponsor

Source ClinicalTrials.gov

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