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Active, Not Recruiting

NCT Number: NCT07219706

Dietary Fiber and Time Restricted Eating

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diet Habits Behavior Behavior, Animal Body Weight Body Weight Changes Cancer Prevention Fasting Feeding Behavior Intermittent Fasting Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Oklahoma Health Sciences

Columbus, Ohio, 43230, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time restricted eating

Behavioral

10-hour Time Restricted Eating (TRE)

Group Education

Behavioral

Group education about dietary fiber

Counseling

Behavioral

Counseling and motivational interviewing to promote uptake of diet changes

Primary outcomes

  1. Dietary fiber intake

    Time frame: 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 outcomes

  1. Body mass/weight

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

    Body mass/weight will be measured in kilograms

  2. Blood pressure

    Time frame: 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])

  3. Blood-based measures of inflammation

    Time frame: 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).

  4. Blood-based measures of oxidative stress

    Time frame: 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

  5. Blood-based measures of insulin resistance

    Time frame: 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)

  6. Affect

    Time frame: Daily for three months

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

  7. Sleep

    Time frame: Daily for three months

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

  8. Physical Activity

    Time frame: Daily for three months

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

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Registry information

Official study title

Examining 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

Acronym: FIBER+TRE

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Oct 22, 2025
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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