Time Restricted Eating for Cognitive Impairment (TEMPO Trial)

N/A

Recruiting

Led By Patrick J Smith, PhD, MPH

Research Sponsored by University of North Carolina, Chapel Hill

Eligibility Criteria Checklist

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

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline and 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a 12-week diet intervention may help improve metabolic function and reduce cognitive impairment in people with mild cognitive impairment.

Who is the study for?

This trial is for men and women aged 65-80 with mild cognitive impairment (MoCA score 19-25) who are sedentary, obese (BMI 30-40), and willing to participate in a time-restricted eating intervention. Excluded are those with heart failure, severe kidney disease, major psychiatric disorders, insulin-dependent diabetes, heavy alcohol use (>14 drinks/week), or any condition that limits exercise.

What is being tested?

The study tests the feasibility of a 12-week time restricted eating plan among older adults with mild cognitive impairment. It aims to see if this dietary approach can improve both metabolic function and cognition as an easy-to-implement strategy potentially reducing the risk of Alzheimer's disease.

What are the potential side effects?

While not explicitly stated, potential side effects may include hunger discomforts during fasting periods, possible changes in energy levels or mood swings due to alterations in usual meal patterns.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline and 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline and 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and 12 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

Executive Function

Memory

Secondary study objectives

Inflammatory Function

Metabolic Flexibility

Awards & Highlights

No Placebo-Only Group

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

Trial Design

1Treatment groups

Experimental Treatment

Group I: Time restricted eatingExperimental Treatment1 Intervention

Participants will engage in a 12-week time restricted fasting intervention. Each week, participants will work with a clinical psychologist to modify the timing of their eating behaviors to adhere to a 16-hour fast, 2-3 days per week.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Time restricted eating

2021

N/A

~130

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