Dietary Fiber and Time Restricted Eating

Not Applicable

Recruiting

• Conditions: Diet Habits; Cancer Prevention

• Registration Number: NCT07219706
• Lead Sponsor: University of Oklahoma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-20
• Study First Submitted QC: 2025-10-20
• Study First Posted: 2025-10-22
• Last Update Submitted: 2025-10-22
• Last Update Posted: 2025-10-24
• Study Start: 2025-12-01
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Dietary fiber intake	Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)	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 Outcome Measures

Name	Time	Method
Body mass/weight	Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)	Body mass/weight will be measured in kilograms
Blood pressure	Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)	Blood pressure (systolic and diastolic) will be measured at each time frame (in millimeters of mercury \[mmHg\])
Blood-based measures of inflammation	Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)	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).
Blood-based measures of oxidative stress	Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)	Venous blood samples will be collected and analyzed for measures of oxidative stress, including reactive oxygen species and lipid peroxidation
Blood-based measures of insulin resistance	Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)	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)
Affect	Daily for three months	Self-reported affect will be assessed using ecological momentary assessment, delivered via cell phone
Sleep	Daily for three months	Sleep will be measured via Fitbits, assessed as mean minutes/night
Physical Activity	Daily for three months	Physical activity will be measured via Fitbits, assessed as mean steps/day

Trial Locations

Locations (1)

University of Oklahoma Health Sciences; 🇺🇸 Columbus, Ohio, United States