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Behavioural Intervention

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

TEMPO Trial 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.Check my eligibility
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.See study design
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.

TEMPO Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Executive Function
Memory
Secondary outcome measures
Inflammatory Function
Metabolic Flexibility

TEMPO 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

Find a Location

Who is running the clinical trial?

National Institutes of Health (NIH)NIH
2,720 Previous Clinical Trials
7,494,406 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,521 Previous Clinical Trials
4,196,590 Total Patients Enrolled
Duke UniversityOTHER
2,384 Previous Clinical Trials
3,427,495 Total Patients Enrolled

Media Library

Time Restricted Eating (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05997316 — N/A
Mild Cognitive Impairment Research Study Groups: Time restricted eating
Mild Cognitive Impairment Clinical Trial 2023: Time Restricted Eating Highlights & Side Effects. Trial Name: NCT05997316 — N/A
Time Restricted Eating (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05997316 — N/A
~16 spots leftby Jan 2025
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