FastingMeta-SHIFTNCT07527208
The Meta-SHIFT Study: How Metabolic Shift Shapes Human Immunometabolism - a Fasting Trial
A study testing Fasting in people with Fasting, run by Cornell University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Fasting
- What is being tested?
- Fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2026to 2 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
- Participation in another biomedical study during this study
Trial locations and contacts
1 site in 1 country.
United States1 site
Human Metabolic Research Unit, Division of Nutritional Sciences. Cornell University
Ithaca, New York, 14853
About this study
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.
Read the detailed description
Rationale: Fasting leads to changes in metabolism and immune function. However, the specific biological connections between these processes are not fully understood. By studying how fasting affects immune cells, this study aims to clarify the bidirectional relationship between metabolism and immune function.
Objectives: The primary objective is to investigate the impact of fasting on immune cells known as peripheral blood mononuclear cells (PBMCs) in healthy adults. The study will examine four main features of these cells:
- change in basal PBMC energy metabolism;
- change in activated PBMC energy metabolism;
- change in the inflammatory capacity of activated PBMCs; and
- change in PBMC subset abundance.
The secondary objectives are to 1) study how fasting affects PBMC gene expression (whole genome single cell transcriptome) and blood metabolites, 2) identify relationships between changes in metabolites and changes in immune cell function and gene expression, and 3) investigate how fasting-induced changes in gene expression are affected by refeeding. In addition, the explorative objectives are to determine how fasting affects the immune cell population residing in subcutaneous adipose.
Study design: The Meta-SHIFT study is a single-arm intervention study that investigates the effect of fasting by comparing the same subjects 2 hours after meal consumption (fed state or 'baseline') and 24 hours after baseline (fasted state or '24 hours'). Participants will serve as their own control.
Study Population: The study will include twenty-eight healthy adults between 18 and 40 years old, who have a body mass index (BMI) between 18.5-24.9 kg/m2 and no chronic diseases.
Intervention: The evening before the fasting intervention, research participants will consume a standardized dinner (ad libitum). The next morning, two hours before baseline, participants will receive a standardized breakfast shake (energy adjusted for BMR), followed by a fasting period of 26 hours. During the fasting period, research participants are not allowed to eat or drink anything except for water and sugar-free tea provided by the investigators, which may be consumed ad libitum. Two hours after the consumption of the standardized shake, the participants are considered to be in the 'fed state', which is defined as baseline. At baseline, the first blood samples (and optional adipose tissue biopsy) will be taken. At 24 hours after baseline, the participants are considered to be in the 'fasted state', and the second set of blood samples (and optional adipose tissue biopsy) will be taken. A period of 24 hours between sampling points is chosen to prevent the effects of circadian rhythm on the outcome measures. Additionally, the effects of re-introducing food after fasting will be examined (refed state). The refed state is defined as 2 hours after consumption of the second standardized breakfast shake that ends the fasted state, which is 26 hours after baseline. At 26-hours, the third set of blood samples will be collected.
- Conditions
- Fasting
- Being tested
- Fasting
- Keywords
- Fasting, PBMC, Adipose tissue, Energy metabolism
- Medical subject headings
- Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FastingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Fasting | Experimental | 26-hour fasting Receives: Other: Fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 24 hours
Change in PBMC subset abundance.
Change from baseline PBMC subset counts, as assessed with a hematology analyzer.
Measured: Baseline, 24 hours
Secondary outcomes (3)
Change in PBMC transcriptome.
Change from baseline whole genome single cell RNA expression in PBMCs at 24 hours.
Measured: Baseline, 24 hours
Change in plasma metabolite profile.
Change from baseline plasma metabolite levels at 24 hours.
Measured: 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.
Measured: Baseline, 24 hours, 26 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start1 Jun 2026
- Primary completion2 Sep 2026
- Study completion2 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for FastingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sander Kersten, Ph.D., Principal investigator, Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527208
- Sponsor's protocol ID
- IRB0149920
- Acronym
- Meta-SHIFT
- Status last verified
- Sep 2026
- First submitted
- 26 Mar 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32504883
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Meta-SHIFT Study: How Metabolic Shift Shapes Human Immunometabolism - a Fasting Trial
- ClinicalTrials.gov ID
- NCT07527208
- Acronym / sponsor ID
- Meta-SHIFT / IRB0149920
- Conditions
- Fasting
- Keywords
- Fasting, PBMC, Adipose tissue, Energy metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cornell UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (actual)
- Primary completion
- 2 Sep 2026 (actual)
- Study completion
- 2 Sep 2026 (actual)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Rationale: Fasting leads to changes in metabolism and immune function. However, the specific biological connections between these processes are not fully understood. By studying how fasting affects immune cells, this study aims to clarify the bidirectional relationship between metabolism and immune function.
Objectives: The primary objective is to investigate the impact of fasting on immune cells known as peripheral blood mononuclear cells (PBMCs) in healthy adults. The study will examine four main features of these cells:
- change in basal PBMC energy metabolism;
- change in activated PBMC energy metabolism;
- change in the inflammatory capacity of activated PBMCs; and
- change in PBMC subset abundance.
The secondary objectives are to 1) study how fasting affects PBMC gene expression (whole genome single cell transcriptome) and blood metabolites, 2) identify relationships between changes in metabolites and changes in immune cell function and gene expression, and 3) investigate how fasting-induced changes in gene expression are affected by refeeding. In addition, the explorative objectives are to determine how fasting affects the immune cell population residing in subcutaneous adipose.
Study design: The Meta-SHIFT study is a single-arm intervention study that investigates the effect of fasting by comparing the same subjects 2 hours after meal consumption (fed state or 'baseline') and 24 hours after baseline (fasted state or '24 hours'). Participants will serve as their own control.
Study Population: The study will include twenty-eight healthy adults between 18 and 40 years old, who have a body mass index (BMI) between 18.5-24.9 kg/m2 and no chronic diseases.
Intervention: The evening before the fasting intervention, research participants will consume a standardized dinner (ad libitum). The next morning, two hours before baseline, participants will receive a standardized breakfast shake (energy adjusted for BMR), followed by a fasting period of 26 hours. During the fasting period, research participants are not allowed to eat or drink anything except for water and sugar-free tea provided by the investigators, which may be consumed ad libitum. Two hours after the consumption of the standardized shake, the participants are considered to be in the 'fed state', which is defined as baseline. At baseline, the first blood samples (and optional adipose tissue biopsy) will be taken. At 24 hours after baseline, the participants are considered to be in the 'fasted state', and the second set of blood samples (and optional adipose tissue biopsy) will be taken. A period of 24 hours between sampling points is chosen to prevent the effects of circadian rhythm on the outcome measures. Additionally, the effects of re-introducing food after fasting will be examined (refed state). The refed state is defined as 2 hours after consumption of the second standardized breakfast shake that ends the fasted state, which is 26 hours after baseline. At 26-hours, the third set of blood samples will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fasting | Experimental | Other: Fasting26-hour fasting |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FastingAfter 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. | Other | Fasting |
Primary outcome
Change in PBMC energy metabolism.
Time frame: Baseline, 24 hours
Change from baseline PBMC glucose dependence (%) and mitochondrial dependence (%) at 24-hours, as measured by the flow cytometry-based CENCAT method.
Change in activated PBMC energy metabolism.
Time frame: Baseline, 24 hours
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.
Change in inflammatory capacity of activated PBMCs.
Time frame: Baseline, 24 hours
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.
Change in PBMC subset abundance.
Time frame: Baseline, 24 hours
Change from baseline PBMC subset counts, as assessed with a hematology analyzer.
3 secondary outcomes
Change in PBMC transcriptome.
Time frame: Baseline, 24 hours
Change in plasma metabolite profile.
Time frame: Baseline, 24 hours
Change in PBMC RNA expression.
Time frame: Baseline, 24 hours, 26 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Background: PubMed 32504883Ruppert 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sander Kersten, Ph.D. principal investigator
Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fasting in people with Fasting, run by Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in PBMC energy metabolism. (time frame: Baseline, 24 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07527208, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.