NCT07219706

Brief Summary

This study is seeking to examine combinations of two different dietary interventions on cancer risk.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Dec 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 22, 2025

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 10, 2026

Expected
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

March 13, 2026

Status Verified

March 1, 2026

Enrollment Period

7 months

First QC Date

October 20, 2025

Last Update Submit

March 11, 2026

Conditions

Diet HabitsCancer Prevention

Keywords

DietWeight lossFastingTime restricted eatingTime restricted feeding

Outcome Measures

Primary Outcomes (1)

  • Dietary fiber intake

    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

    Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)

Secondary Outcomes (8)

  • Body mass/weight

    Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)

  • Blood pressure

    Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)

  • Blood-based measures of inflammation

    Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)

  • Blood-based measures of oxidative stress

    Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)

  • Blood-based measures of insulin resistance

    Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)

  • +3 more secondary outcomes

Study Arms (3)

Fiber for Improvement of Behavior, Eating, and Risk (FIBER)

EXPERIMENTAL
Behavioral: Group educationBehavioral: Counseling

Time Restricted Eating (TRE)

EXPERIMENTAL
Behavioral: Time Restricted Eating

FIBER and TRE

EXPERIMENTAL
Behavioral: Time Restricted EatingBehavioral: Group educationBehavioral: Counseling

Interventions

Time Restricted EatingBEHAVIORAL

10-hour Time Restricted Eating (TRE)

FIBER and TRETime Restricted Eating (TRE)
Group educationBEHAVIORAL

Group education about dietary fiber

FIBER and TREFiber for Improvement of Behavior, Eating, and Risk (FIBER)
CounselingBEHAVIORAL

Counseling and motivational interviewing to promote uptake of diet changes

FIBER and TREFiber for Improvement of Behavior, Eating, and Risk (FIBER)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥18 age
  • Body mass index ≥30 kg/m2
  • Dietary fiber intake ≤15 g/day
  • Compatible cell phone for use of ecological momentary assessment app

You may not qualify if:

  • 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
  • Currently pregnant or breastfeeding, or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oklahoma Health Sciences

Columbus, Ohio, 43230, United States

RECRUITING

MeSH Terms

Conditions

Feeding BehaviorWeight LossFastingIntermittent Fasting

Interventions

Counseling

Condition Hierarchy (Ancestors)

Behavior, AnimalBehaviorBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Central Study Contacts

Ashlea Braun, PhD

CONTACT

15672401582ashlea-braun@ou.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2025

First Posted

October 22, 2025

Study Start (Estimated)

December 10, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

March 13, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)