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FIBER+TRE

Dietary Fiber and Time Restricted Eating on Cancer Risk

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What is being tested

Time Restricted Eating

+ Group education
+ Counseling
Behavioral
Who is being recruted

Diet Habits

+ Cancer Prevention
Over 18 Years
+9 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Prevention Study

Interventional
Study Start: December 2025

See protocol details

Summary

Principal SponsorUniversity of Oklahoma
Study ContactAshlea Braun, PhD
Last updated: October 24, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: December 1, 2025Actual date on which the first participant was enrolled.

This study focuses on understanding how two specific dietary changes might influence the risk of developing cancer. It looks at the effects of increasing dietary fiber and practicing time-restricted eating, either separately or together, to see if they can help reduce cancer risk. People interested in preventing cancer or those at risk might find this study particularly relevant, as it explores simple, everyday changes in eating habits that could potentially lead to healthier outcomes. Participants in the study will follow specific dietary guidelines, which include increasing the amount of fiber in their diets and/or limiting their eating to certain times of the day. Researchers will monitor various health indicators to assess how these dietary changes impact cancer risk. While the study does not list specific outcomes or risks, the goal is to evaluate whether these dietary interventions can be beneficial in lowering the chances of developing cancer. This could offer new insights into simple dietary strategies for cancer prevention.

Official TitleExamining the Independent and Combined Effects of Dietary Fiber and Time Restricted Eating on Indicators of Cancer Risk: the Fiber and Time Restricted Eating (F.I.T.) Study 
Principal SponsorUniversity of Oklahoma
Study ContactAshlea Braun, PhD
Last updated: October 24, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
90 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants receive different combinations of treatments to see how they work together. This approach helps researchers determine whether a combination of treatments is more effective than a single treatment alone.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Diet Habits
Cancer Prevention
Criteria
4 inclusion criteria required to participate
≥18 age
Body mass index ≥30 kg/m2
Dietary fiber intake ≤15 g/day
Compatible cell phone for use of ecological momentary assessment app
5 exclusion criteria prevent from participating
Self-reported diagnosis that precludes fiber intake (e.g., inflammatory bowel disease)
Food allergies or intolerances that limit ability to engage with the intervention
Positive screen on the SCOFF eating disorder screener39
Current self-reported use of GLP-1 receptor agonists

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
3 intervention groups 

are designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
Group II
Experimental
Group III
Experimental
Study Objectives
Primary Objectives

Dietary fiber intake as reported on 3-day diet records and analyzed according to Nutrition Data System for Research; reported as a mean intake over three days in grams per day
Secondary Objectives

Body mass/weight will be measured in kilograms

Blood pressure (systolic and diastolic) will be measured at each time frame (in millimeters of mercury \[mmHg\])

Venous blood samples will be collected and analyzed for inflammatory markers: Granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon-gamma (IFN-γ), interleukin-1 beta (IL-1β), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-α).

Venous blood samples will be collected and analyzed for measures of oxidative stress, including reactive oxygen species and lipid peroxidation

Insulin resistance will be measured via assessment of insulin and glucose in venous blood samples, and used to assess Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

Self-reported affect will be assessed using ecological momentary assessment, delivered via cell phone

Sleep will be measured via Fitbits, assessed as mean minutes/night

Physical activity will be measured via Fitbits, assessed as mean steps/day

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 1 location
Recruiting
University of Oklahoma Health SciencesColumbus, United StatesSee the location
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One Study Center