This study is seeking to examine combinations of two different dietary interventions on cancer risk.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
90
10-hour Time Restricted Eating (TRE)
Group education about dietary fiber
Counseling and motivational interviewing to promote uptake of diet changes
University of Oklahoma Health Sciences
Columbus, Ohio, United States
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)
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)
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)
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)
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)
Blood-based measures of insulin resistance
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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)
Time frame: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Affect
Self-reported affect will be assessed using ecological momentary assessment, delivered via cell phone
Time frame: Daily for three months
Sleep
Sleep will be measured via Fitbits, assessed as mean minutes/night
Time frame: Daily for three months
Physical Activity
Physical activity will be measured via Fitbits, assessed as mean steps/day
Time frame: Daily for three months