EvaluatingNCT07513116
Evaluating Intermittent Fasting In Individuals At High Risk ForPancreatic Cancer Undergoing Screening
A study testing intermittent fasting in people with Evaluating and Intermittent Fasting, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To learn whether an eating pattern called intermittent fasting (IF) is tolerable and feasible for individuals at high risk of pancreatic cancer and whether IF is associated with changes in biological markers, including metabolic, inflammatory, microbiome, and imaging-related markers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluating, Intermittent Fasting, Pancreatic Cancer
- What is being tested?
- intermittent fasting
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants ≥ 18 years old. Participants under 18 are excluded due to their potential inability to understand and consent independently to the methods required for the study drug use and its potential risks and benefits.
- Participants evaluated and classified as high risk for pancreatic cancer through a High-Risk Pancreatic Cancer Clinic or High-Risk Pancreatic Cyst Clinic, based on established clinical assessment and risk stratification.
- High-risk status may include one or more of the following:
- Hereditary cancer syndromes or known pathogenic germline mutations associated with pancreatic cancer risk
- Family history of pancreatic ductal adenocarcinoma (PDAC)
- Presence of pancreatic cysts or precursor lesions (e.g., IPMN, MCN)
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- New-onset diabetes mellitus is considered suspicious for pancreatic cancer
- History of recurrent or chronic pancreatitis
- Eligibility and surveillance risk assessment must be consistent with NCCN (National Comprehensive Cancer Network) Guidelines for Pancreatic Cancer Screening in High- Risk Individuals.
- Participants are able to understand and are willing to sign a written informed consent document.
- Both English-speaking and non-English-speaking participants are eligible for participation
- Participants are willing to make a change in eating time patterns.
- Participants are willing to provide App-tracked fasting time data over the course of the study.
Who cannot join
- BMI < 18.5 Kg/m2
- Documented history of symptomatic hypoglycemia
- Pregnant or breastfeeding women
- Cognitively impaired individuals
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Florencia McAllister, MD, 713-745-0914, fmcallister@mdanderson.org
Florencia McAllister, MD
About this study
To learn whether an eating pattern called intermittent fasting (IF) is tolerable and feasible for individuals at high risk of pancreatic cancer and whether IF is associated with changes in biological markers, including metabolic, inflammatory, microbiome, and imaging-related markers.
Read the detailed description
Primary Objectives
- To assess the tolerability and feasibility of Intermittent fasting (IF) in participants at high risk for pancreatic cancer.
Secondary Objectives
- To assess changes in oral and gut microbiome after IF.
- To assess changes in metabolomic markers after IF.
- To assess changes in inflammatory markers after IF.
- Conditions
- Evaluating, Intermittent Fasting, Pancreatic Cancer
- Being tested
- intermittent fasting
- Medical subject headings
- Intermittent Fasting, Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent fastingOther
They will fast for 16 consecutive hours each day and have an 8-hour window for eating.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting | Experimental | Fast for 16 consecutive hours each day and have an 8-hour window for eating. Receives: Other: intermittent fasting |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs).
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Measured: Through study completion; an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start10 Jun 2026
- Primary completion30 Mar 2027 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EvaluatingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florencia McAllister, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07513116
- Sponsor's protocol ID
- 2026-0227
- Other IDs
- NCI-2026-02451
- Status last verified
- Oct 2026
- First submitted
- 1 Apr 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Intermittent Fasting In Individuals At High Risk ForPancreatic Cancer Undergoing Screening
- ClinicalTrials.gov ID
- NCT07513116
- Acronym / sponsor ID
- 2026-0227
- Conditions
- Evaluating, Intermittent Fasting, Pancreatic Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- 30 Mar 2027 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 6 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.
To learn whether an eating pattern called intermittent fasting (IF) is tolerable and feasible for individuals at high risk of pancreatic cancer and whether IF is associated with changes in biological markers, including metabolic, inflammatory, microbiome, and imaging-related markers.
Detailed description
Primary Objectives
- To assess the tolerability and feasibility of Intermittent fasting (IF) in participants at high risk for pancreatic cancer.
Secondary Objectives
- To assess changes in oral and gut microbiome after IF.
- To assess changes in metabolomic markers after IF.
- To assess changes in inflammatory markers after IF.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting | Experimental | Other: intermittent fastingFast for 16 consecutive hours each day and have an 8-hour window for eating. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Participants ≥ 18 years old. Participants under 18 are excluded due to their potential inability to understand and consent independently to the methods required for the study drug use and its potential risks and benefits.
- Participants evaluated and classified as high risk for pancreatic cancer through a High-Risk Pancreatic Cancer Clinic or High-Risk Pancreatic Cyst Clinic, based on established clinical assessment and risk stratification.
- High-risk status may include one or more of the following:
- Eligibility and surveillance risk assessment must be consistent with NCCN (National Comprehensive Cancer Network) Guidelines for Pancreatic Cancer Screening in High- Risk Individuals.
- Participants are able to understand and are willing to sign a written informed consent document.
Key exclusion criteria (4 listed)
- BMI < 18.5 Kg/m2
- Documented history of symptomatic hypoglycemia
- Pregnant or breastfeeding women
- Cognitively impaired individuals
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 |
|---|---|---|
| intermittent fastingThey will fast for 16 consecutive hours each day and have an 8-hour window for eating. | Other | Intermittent fasting |
Primary outcome
Safety and adverse events (AEs).
Time frame: Through study completion; an average of 1 year.
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Florencia McAllister, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intermittent fasting in people with Evaluating and Intermittent Fasting, run by M.D. Anderson Cancer Center 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 13 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 Oct 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Florencia McAllister, MD (713-745-0914, fmcallister@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs). (time frame: Through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.