Dietary Fiber and Time Restricted Eating
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Oklahoma
About this trial
This study is seeking to examine combinations of two different dietary interventions on cancer risk.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
≥18 age
Body mass index ≥30 kg/m2
Dietary fiber intake ≤15 g/day
Compatible cell phone for use of ecological momentary assessment app
Disqualifiers
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
Trial design
Design model
Factorial
Treatments tested in this trial
Time Restricted Eating
Behavioral10-hour Time Restricted Eating (TRE)
Group education
BehavioralGroup education about dietary fiber
Counseling
BehavioralCounseling and motivational interviewing to promote uptake of diet changes
Treatment groups
90 Participants
are divided into 3 treatment groupsGroup A: Fiber for Improvement of Behavior, Eating, and Risk (FIBER)Experimental treatment 2 interventions
Group B: Time Restricted Eating (TRE)Experimental treatment 1 intervention
Group C: FIBER and TREExperimental treatment 3 interventions
Trial outcomes
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
Time frame
Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)Secondary outcomes
1
Body mass/weight
Body mass/weight will be measured in kilograms
Time frame
Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)2
Blood pressure
Blood pressure (systolic and diastolic) will be measured at each time frame (in millimeters of mercury \[mmHg\])
Time frame
Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)3
Blood-based measures of inflammation
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).
Time frame
Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)4
Blood-based measures of oxidative stress
Venous blood samples will be collected and analyzed for measures of oxidative stress, including reactive oxygen species and lipid peroxidation
Time frame
Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)Sponsors and contacts
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Source ClinicalTrials.gov