What side effects are associated with this type of intervention?

Intermittent fasting, including early time-restricted eating (eTRE), can lead to several side effects. Commonly reported issues include increased hunger, irritability, dizziness, and fatigue, especially during the initial adaptation period. Some individuals may also experience headaches, difficulty concentrating, and sleep disturbances. These side effects are generally temporary and tend to diminish as the body adjusts to the new eating schedule.

What prior FDA approvals exist?

There are no FDA-approved treatments specifically for intermittent fasting or early time-restricted eating. However, several drugs have been approved for related metabolic conditions. For instance, GLP-1 receptor agonists like liraglutide and semaglutide are approved for weight management and type 2 diabetes, showing benefits in glycemic control and weight reduction. These drugs could potentially complement dietary interventions like intermittent fasting by improving metabolic outcomes.

What other types of research exist?

Promising alternatives to early time-restricted eating for intermittent fasting patients include: 1) Cholecystokinin (CCK) analogs or agents that enhance endogenous CCK release, which can delay gastric emptying and improve glycemic control. 2) Oligofructose supplements, which promote satiety and reduce hunger, potentially aiding in weight management. 3) Strategic use of melatonin in the evenings to regulate sleep-wake cycles, which can indirectly influence metabolic processes. These alternatives offer novel approaches to managing metabolic health and appetite in intermittent fasting patients.

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Early Time-Restricted Eating for Improved Muscle Performance

N/A

Recruiting

Research Sponsored by University of Mississippi, Oxford

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial tests if eating all meals earlier in the day can improve muscle performance and body composition in active adults who do resistance training.

Who is the study for?

This trial is for adults aged 18-50 who are not underweight (BMI ≥ 18.5) and have been doing resistance training at least twice a week for over a year. It's not suitable for current smokers, those with recent major health issues like cancer or heart disease, diagnosed eating disorders, or anyone on restrictive diets.

What is being tested?

The study tests if eating within an early time-restricted window affects muscle performance in people who lift weights regularly. Participants will either follow the restricted eating plan or continue normal eating while maintaining their exercise routine over six weeks.

What are the potential side effects?

Potential side effects may include changes in hunger and fullness levels, alterations in sleep quality, and possible challenges to energy intake and diet quality due to the restricted eating timeframe.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-weeks for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Muscular endurance

Muscular strength

Secondary study objectives

Adherence

Body fat percentage

Body weight (kg)

+7 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: early time-restricted eatingExperimental Treatment1 Intervention

The Early Time Restricted Eating (eTRE) group will be asked to consume calorie containing food or drinks only between 9am to 5pm, daily. At other times they are to avoid consuming any calorie containing food or drinks.

Group II: ControlActive Control1 Intervention

The Control group will follow their usual eating routine.

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

Early Time-Restricted Eating (TRE) involves consuming all meals within a specific time window earlier in the day, aligning with the body's natural circadian rhythms. This approach can improve insulin sensitivity, enhance fat oxidation, and reduce appetite, which are essential for better weight management and metabolic health. These mechanisms are crucial for Intermittent Fasting patients as they help optimize metabolic outcomes and potentially reduce the risk of chronic diseases.

Exenatide once weekly slows gastric emptying of solids and liquids in healthy, overweight people at steady-state concentrations.Effect of liraglutide on food consumption, appetite sensations and eating behaviours in overweight people with type 1 diabetes.Mesenchymal stromal cells to halt the progression of type 1 diabetes?