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
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