Dietary Fiber and Time Restricted Eating (FIBER+TRE)

University of Oklahoma (OU)

Status: Enrolling

Conditions: Cancer Prevention; Diet Habits

Treatments: Behavioral: Counseling; Behavioral: Group education; Behavioral: Time Restricted Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT07219706

18665

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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90 participants in 3 patient groups

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

Experimental group

Treatment:

Behavioral: Counseling

Behavioral: Group education

Time Restricted Eating (TRE)

Experimental group

Treatment:

Behavioral: Time Restricted Eating

FIBER and TRE

Experimental group

Treatment:

Behavioral: Time Restricted Eating

Behavioral: Counseling

Behavioral: Group education