Diet HabitsFIBER+TRENCT07219706
Dietary Fiber and Time Restricted Eating
A study testing Time Restricted Eating, Group education and Counseling in people with Diet Habits and Cancer Prevention, run by University of Oklahoma at 1 site in United States.
Trial summary
This study is seeking to examine combinations of two different dietary interventions on cancer risk. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diet Habits, Cancer Prevention
- What is being tested?
- Time Restricted Eating, Group education and Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Dec 2025to 30 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ≥18 age
- Body mass index ≥30 kg/m2
- Dietary fiber intake ≤15 g/day
- Compatible cell phone for use of ecological momentary assessment app
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences
Columbus, Ohio, 43230
About this study
Official 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
This study is seeking to examine combinations of two different dietary interventions on cancer risk.
- Conditions
- Diet Habits, Cancer Prevention
- Being tested
- Time Restricted Eating, Group education, Counseling
- Keywords
- Diet, Weight loss, Fasting, Time restricted eating, Time restricted feeding
- Medical subject headings
- Feeding Behavior, Weight Loss, Fasting, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingBehavioural
10-hour Time Restricted Eating (TRE)
Group educationBehavioural
Group education about dietary fiber
CounselingBehavioural
Counseling and motivational interviewing to promote uptake of diet changes
| Study group | Role | What they receive |
|---|---|---|
| Fiber for Improvement of Behavior, Eating, and Risk (FIBER) | Experimental | Not described Receives: Behavioral: Group education; Behavioral: Counseling |
| Time Restricted Eating (TRE) | Experimental | Not described Receives: Behavioral: Time Restricted Eating |
| FIBER and TRE | Experimental | Not described Receives: Behavioral: Time Restricted Eating; Behavioral: Group education; Behavioral: Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Secondary outcomes (8)
Body mass/weight
Body mass/weight will be measured in kilograms
Measured: 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])
Measured: 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).
Measured: 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
Measured: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Blood-based measures of insulin resistance
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)
Measured: 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
Measured: Daily for three months
Sleep
Sleep will be measured via Fitbits, assessed as mean minutes/night
Measured: Daily for three months
Physical Activity
Physical activity will be measured via Fitbits, assessed as mean steps/day
Measured: Daily for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2025
- Study start10 Dec 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet HabitsStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07219706
- Sponsor's protocol ID
- 18665
- Acronym
- FIBER+TRE
- Status last verified
- Jul 2026
- First submitted
- 20 Oct 2025
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07219706
- Acronym / sponsor ID
- FIBER+TRE / 18665
- Conditions
- Diet Habits, Cancer Prevention
- Keywords
- Diet, Weight loss, Fasting, Time restricted eating, Time restricted feeding
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 22 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is seeking to examine combinations of two different dietary interventions on cancer risk.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fiber for Improvement of Behavior, Eating, and Risk (FIBER) | Experimental | Behavioral: Group education, Behavioral: Counseling |
| Time Restricted Eating (TRE) | Experimental | Behavioral: Time Restricted Eating |
| FIBER and TRE | Experimental | Behavioral: Time Restricted Eating, Behavioral: Group education, Behavioral: Counseling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ≥18 age
- Body mass index ≥30 kg/m2
- Dietary fiber intake ≤15 g/day
- Compatible cell phone for use of ecological momentary assessment app
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time Restricted Eating10-hour Time Restricted Eating (TRE) | Behavioural | FIBER and TRE, Time Restricted Eating (TRE) |
| Group educationGroup education about dietary fiber | Behavioural | FIBER and TRE, Fiber for Improvement of Behavior, Eating, and Risk (FIBER) |
| CounselingCounseling and motivational interviewing to promote uptake of diet changes | Behavioural | FIBER and TRE, Fiber for Improvement of Behavior, Eating, and Risk (FIBER) |
Primary outcome
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
8 secondary outcomes
Body mass/weight
Time frame: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Blood pressure
Time frame: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Blood-based measures of inflammation
Time frame: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Blood-based measures of oxidative stress
Time frame: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Blood-based measures of insulin resistance
Time frame: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)
Affect
Time frame: Daily for three months
Sleep
Time frame: Daily for three months
Physical Activity
Time frame: Daily for three months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No
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Dietary Habits
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time Restricted Eating, Group education and Counseling in people with Diet Habits and Cancer Prevention, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dietary fiber intake (time frame: Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.