What side effects are associated with this type of intervention?

Time Restricted Eating (TRE), a form of intermittent fasting, is generally well-tolerated but can have some side effects. Common side effects include hunger, irritability, and reduced concentration during fasting periods. Some individuals may experience headaches, dizziness, or gastrointestinal issues such as constipation or bloating. It is important to stay hydrated and ensure adequate nutrient intake during eating windows to mitigate these effects. As with any dietary regimen, it is advisable to consult with a healthcare provider before starting TRE, especially for individuals with underlying health conditions.

What prior FDA approvals exist?

There are currently no FDA-approved treatments specifically for intermittent fasting or time-restricted eating. However, research is ongoing into the potential benefits of these dietary practices, particularly their effects on endothelial function and neurovascular responses through the activation of SIRT1-dependent vasoprotective pathways. While no drugs are approved for this purpose, the study of such mechanisms may inform future therapeutic developments.

What other types of research exist?

Promising alternatives to Time Restricted Eating for intermittent fasting patients include: 1) Caloric restriction, which has shown benefits in metabolic health and longevity. 2) Low glycemic index diets, which may help in managing blood glucose levels. 3) High-fiber diets, which can improve glycemic control and overall metabolic health. 4) Mindfulness-based interventions, which can aid in self-regulation and stress reduction. 5) Video game-based interventions like Endeavor Rx, which have shown potential in improving attention function in children with ADHD and could be explored for cognitive benefits in adults.

← Back to Search

Behavioural Intervention

Time-Restricted Eating for Intermittent Fasting

N/A

Waitlist Available

Led By Stefano Tarantini, PhD

Research Sponsored by University of Oklahoma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, up to 6 months

Awards & highlights

Study Summary

This trialaims to see if eating within a certain time window can improve blood vessel health and thinking skills.

Who is the study for?

This trial is for healthy adults who are at least 21 years old. Participants must be able to read and write in English.Check my eligibility

What is being tested?

The study tests if sticking closely to a time-restricted eating schedule can improve blood vessel function, brain blood flow responses, and thinking skills in older adults through certain protective pathways.See study design

What are the potential side effects?

Since the intervention involves dietary changes rather than medication, side effects may include hunger, fatigue or irritability due to altered meal times.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, up to 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)

Change in neurovascular coupling using the dynamic retinal vessel analysis

Change in neurovascular coupling using transcranial Doppler

Secondary outcome measures

Change in Attention

Change in ECG

Change in Episodic Memory

+11 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Time restricted eatingExperimental Treatment1 Intervention

not more than 10 hrs. eating window daily goal for 6 months

Group II: ControlActive Control1 Intervention

no intervention

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Time Restricted Eating (TRE), a form of Intermittent Fasting, involves consuming food within a specific time window each day. This practice can activate SIRT1-dependent vasoprotective pathways, which are crucial for improving endothelial function and neurovascular responses. SIRT1 is a protein that regulates cellular processes related to aging and metabolism. By enhancing SIRT1 activity, TRE may improve cognitive performance and vascular health, offering benefits beyond weight loss. This mechanism is significant for patients practicing Intermittent Fasting as it underscores the broader health advantages of TRE, particularly in protecting against vascular and cognitive decline.

Knock-out of a mitochondrial sirtuin protects neurons from degeneration in Caenorhabditis elegans.Sirtuins, aging, and metabolism.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor

455 Previous Clinical Trials

95,646 Total Patients Enrolled

Stefano Tarantini, PhDPrincipal InvestigatorUniversity of Oklahoma

Media Library

Time restricted eating (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05488652 — N/A

Intermittent Fasting Research Study Groups: Control, Time restricted eating

Intermittent Fasting Clinical Trial 2023: Time restricted eating Highlights & Side Effects. Trial Name: NCT05488652 — N/A

Time restricted eating (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05488652 — N/A

~4 spots leftby Jun 2025

Unbiased ResultsWe believe in providing patients with all the options.

Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.

Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.