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.

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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

No Placebo-Only Group

Summary

This trial tests if eating within a specific daily time window can improve blood vessel and brain function in healthy adults, possibly leading to better cognitive performance. Time-restricted eating involves consuming food within a limited daily timeframe, with studies showing preliminary benefits for glucose regulation, insulin sensitivity, and cardiovascular health.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Change in Attention

Change in ECG

Change in Episodic Memory

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

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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.