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

NCT07527208 | Not Yet Recruiting

• 1 other identifier: IRB0149920
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Fasting

Keywords

Fasting; PBMC; Adipose tissue; Energy metabolism

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  Baseline, 24 hours

• Change in PBMC subset abundance.

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

  Baseline, 24 hours

Secondary Outcomes (3)

• Change in PBMC transcriptome.

  Baseline, 24 hours

• Change in plasma metabolite profile.

  Baseline, 24 hours

• Change in PBMC RNA expression.

  Baseline, 24 hours, 26 hours

Other Outcomes (1)

• Change in subcutaneous adipose tissue immune cell transcriptome.

  Baseline, 24 hours

Study Arms (1)

Fasting

EXPERIMENTAL

26-hour fasting

Other: Fasting

Interventions

Fasting OTHER

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.

Fasting

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Signed informed consent

You may not qualify if:

• 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
• Use of any prescribed medications (incl. GLP-1 agonists), except for contraceptives
• Usage of recreational drugs in the last three months
• Unstable body weight (weight gain or loss \>5% of total BW in the past three months)
• Following any restrictive diet within one month of starting the study (for example a ketogenic diet or weight loss diet)
• Fasted for 16 hours or longer in the past week
• History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating disorder)
• Allergic to one or more components of the standardized meal and/or shake (i.e., milk, wheat, and soy)
• Average alcohol intake that exceeds 1 consumption/day or 7 consumptions/week over the past month
• Tobacco smoker or regular use of nicotine products
• Donated or intend to donate blood from 2 months before the study until the end of the study
• Being pregnant or lactating

Sponsors & Collaborators

• Cornell University: lead

Study Sites (1)

Human Metabolic Research Unit, Division of Nutritional Sciences. Cornell University

Ithaca, New York, 14853, United States

Location

Related Publications (1)

• Ruppert PMM, Michielsen CCJR, Hazebroek EJ, Pirayesh A, Olivecrona G, Afman LA, Kersten S. Fasting induces ANGPTL4 and reduces LPL activity in human adipose tissue. Mol Metab. 2020 Oct;40:101033. doi: 10.1016/j.molmet.2020.101033. Epub 2020 Jun 3.

  PMID: 32504883 BACKGROUND

MeSH Terms

Conditions

Fasting

Interventions

Angptl4 protein, mouse

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Sander Kersten, Ph.D.

  Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Larissa van der Zon, MS

CONTACT

607-255-8001; lev36@cornell.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2026
• First Posted: April 14, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): August 28, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)