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Not yet recruiting NCT07513116

Evaluating Intermittent Fasting In Individuals At High Risk ForPancreatic Cancer Undergoing Screening

No phase Interventional Evaluating Intermittent Fasting Pancreatic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: intermittent fasting.
Who it may be relevant to
Registry conditions: Evaluating, Intermittent Fasting, Pancreatic Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other intermittent fasting
    They will fast for 16 consecutive hours each day and have an 8-hour window for eating.

Primary outcome measures

  • Safety and adverse events (AEs). [Time frame: Through study completion; an average of 1 year.]

Eligibility criteria

Inclusion criteria

  • 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)
  • 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.

Exclusion criteria

  • BMI < 18.5 Kg/m2
  • Documented history of symptomatic hypoglycemia
  • Pregnant or breastfeeding women
  • Cognitively impaired individuals

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • MD Anderson Cancer Center — Houston

Identifiers

NCT: NCT07513116 · 2026-0227 · NCI-2026-02451

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗