Evaluating Intermittent Fasting In Individuals At High Ri... | NCT07513116

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

NCT07513116

Sponsor

M.D. Anderson Cancer Center

Status

Not yet recruiting

Last Update Posted

Apr 14, 2026Actual

Enrollment

20Estimated

Phase

Not Applicable

Conditions

Evaluating
Intermittent Fasting
Pancreatic Cancer

Interventions

intermittent fasting

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
NCI-2026-02451	Other Identifier	NCI-CTRP Clinical Registry

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 17, 2026Estimated

Primary Completion Date

Mar 30, 2027Estimated

Completion Date

Mar 30, 2029Estimated

First Submitted Date

Apr 1, 2026

First Submission Date that Met QC Criteria

Apr 1, 2026

First Posted Date

Apr 6, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 13, 2026

Last Update Posted Date

Apr 14, 2026Actual

Description Module

Brief 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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Label	Type	Description	Intervention Names
Intermittent fasting	Experimental	Fast for 16 consecutive hours each day and have an 8-hour window for eating.	Other: intermittent fasting

Name	Type	Description	Arm Group Labels	Other Names
intermittent fasting	Other	They will fast for 16 consecutive hours each day and have an 8-hour window for eating.	Intermittent fasting

Measure	Description	Time Frame
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	Through study completion; an average of 1 year.

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D005215	Fasting
D005247	Feeding Behavior
D001519	Behavior
D004067	Digestive System Neoplasms