Diet Habits, Cancer Prevention
Conditions
Keywords
Diet, Weight loss, Fasting, Time restricted eating, Time restricted feeding
Brief summary
This study is seeking to examine combinations of two different dietary interventions on cancer risk.
Interventions
BEHAVIORALTime Restricted Eating
10-hour Time Restricted Eating (TRE)
BEHAVIORALGroup education
Group education about dietary fiber
BEHAVIORALCounseling
Counseling and motivational interviewing to promote uptake of diet changes
Sponsors
University of Oklahoma
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTAshlea Braun, PhD
Outcome results
None listed