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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
2,701 Previous Clinical Trials
7,506,810 Total Patients Enrolled
University of North Carolina, Chapel HillLead Sponsor
1,508 Previous Clinical Trials
4,190,785 Total Patients Enrolled
Duke UniversityOTHER
2,364 Previous Clinical Trials
3,420,602 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the cutoff age for this trial's participants less than 60 years old?

"This trial is exclusively recruiting individuals aged 65 to 80, but there are 211 trials available for those under 18 and 1203 clinical tests open to seniors."

Answered by AI

Is enrollment still available for this clinical research?

"Affirmative. Clinicaltrials.gov's records show that this trial is actively recruiting participants, with 40 individuals sought out from one site since the study was initially posted on August 7th 2023."

Answered by AI

Is it possible to enrol in this medical experiment?

"This study is seeking 40 volunteers who have mild cognitive impairment and are aged between 65-80. To be eligible, patients must meet these criteria."

Answered by AI

What is the maximum number of participants that are eligible to join this research?

"Affirmative. The clinicaltrials.gov website indicates that this trial is currently in the process of enrolling patients; it was initially posted on August 7th 2023 and was last modified 10 days later. 40 participants are needed at a single research site for this study to be successful."

Answered by AI

Who else is applying?

What site did they apply to?
University of North Carolina
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~21 spots leftby Jan 2025