ClinicalTrials.gg
Active, not recruitingNCT07219706FIBER+TREUpdated Jul 6, 2026

Dietary Fiber and Time Restricted Eating

An interventional study of Time Restricted Eating and Group education in Diet Habits and Cancer Prevention, sponsored by University of Oklahoma. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-06.

Primary conditionIntermittent FastingRegistry: Feeding BehaviorReclassifiedWhy we changed it
Registry
Feeding Behavior — the first condition term the registry derived for this study.
ClinicalTrials.gg
Intermittent Fasting
Why
  1. The study's title name Intermittent Fasting, a narrower term within Feeding Behavior.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Oklahoma · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Diet Habits
  • Cancer Prevention

Browse trials for

Keywords

  • Diet
  • Weight loss
  • Fasting
  • Time restricted eating
  • Time restricted feeding
03

In context

Intermittent Fasting Reclassified

333 studies on the registry are indexed under Intermittent Fasting; 99 are open to participants now.

This study's planned enrollment of 90 is above the median of 50 across 320 interventional studies indexed under Intermittent Fasting.

Browse Intermittent Fasting studies →

Lead sponsor

University of Oklahoma is the lead sponsor of 432 studies on the registry; 100 are open to participants now.

Of its 42 completed or terminated interventional studies of FDA-regulated products, 16 (38%) have results posted.

Compared within Intermittent Fasting, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Feeding Behavior. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • ≥18 age
  • ≥30 kg/m2
  • Dietary fiber intake ≤15 g/day
  • Compatible cell phone for use of ecological momentary assessment app

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    Fiber for Improvement of Behavior, Eating, and Risk (FIBER)

    Behavioral: Group education · Behavioral: Counseling

  • Experimental
    Time Restricted Eating (TRE)

    Behavioral: Time Restricted Eating

  • Experimental
    FIBER and TRE

    Behavioral: Time Restricted Eating · Behavioral: Group education · Behavioral: Counseling

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

06

What researchers measure

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)

  5. 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)

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

  6. Affect

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

    Time frame: Daily for three months

  7. Sleep

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

    Time frame: Daily for three months

  8. Physical Activity

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

    Time frame: Daily for three months

07

Study locations

1 site
  • University of Oklahoma Health Sciences
    Columbus, Ohio 43230, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Jun 2027, 18 months after the start.

Of 257 non-industry interventional studies with no phase under Intermittent Fasting, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 18 months is close to that.

Counting every sponsor, half of 263 studies reached it within 17 months; a quarter within 8 and three quarters within 34.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 20, 2025
First posted
Oct 22, 2025
StartActual
Dec 10, 2025
Primary completionEst.
Jun 30, 2027
CompletionEst.
Jun 30, 2027
Last update
Jul 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07219706
Responsible party
Sponsor
First posted
Oct 22, 2025
Start date
Dec 10, 2025
Primary completion
Jun 30, 2027 (estimated)
Completion
Jun 30, 2027 (estimated)
Last update
Jul 6, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion