Time Restricted Eating for Metabolic and Psychological Optimization (TEMPO)

Assessing the Feasibility and Acceptability of a Time Restricted Feeding Intervention Among Older Adults With Mild Cognitive Impairment

Obesity and related metabolic comorbidities have been associated with more than a 4-fold increased risk of incident cognitive impairment, including Alzheimer's disease and related dementias (ADRD). Dysfunctional metabolic flexibility is increasingly recognized as a critical mechanism linking metabolic risk factors to risk of cognitive impairment, although few studies portable behavioral strategies to enhance metabolic function among individuals at risk for ADRD. The present study will examine the feasibility and acceptability of a 12-week time restricted feeding intervention among individuals with mild cognitive impairment (MCI). Changes in cognitive and metabolic function will also be examined.

Study Overview

• Status: Completed
• Conditions: Obesity; Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: Time restricted eating

Detailed Description

Obese older adults with mild cognitive impairment with mild cognitive impairment will be asked to participate in a 12 week time restricted fasting intervention. Working with a behavioral psychologist, they will adapt the timing their eating patterns to incorporate 2-3 days per week with a 16 hour fasting period, typically lasting from after dinner to lunch the next day. The behavioral intervention will titrate fasting using established behavioral change techniques, with early phase sessions focusing on organizational principles to prepare for weekly fasting scheduling and acceptance-based psychological coping skills, including the ability to tolerate symptoms of hunger and discomfort that may accompany fasting. After treatment initiation, sessions will focus on broadening fasting behaviors for flexible adoption across different contexts and to enhance maintenance of fasting patterns. At baseline and following treatment, participants will undergo tests of cognitive and metabolic function to assess memory, executive function, metabolic flexibility, and inflammation. At both time points, participants will also undergo an abbreviated assessment of cognitive and metabolic function under fasting conditions to assess for any cognitive weaknesses unmasked during periods of brief metabolic 'stress'.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27519
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Subjects will include those men and women:

• aged 65-80 years,
• with amnestic Mild Cognitive Impairment (Montreal Cognitive Assessment Battery score [MoCA] total score 19-25 or a phonemic fluency score of =<12 (with MoCA >25) or semantic fluency score of =<15 (with MoCA >15); and score of > 1.0 on the Mail-in Cognitive Function Screening Instrument),
• obese (body mass index 27.5-40 kg/m^2),
• sedentary, and
• willing to participate in all aspects of the proposed intervention.

Exclusion Criteria:

Reasons for participant exclusion will include:

• secondary causes of obesity,
• evidence of clinical dementia (MoCA score < 18), severe chronic kidney disease (eGFR <45 ml/min/1.73m^2),
• heart failure,
• high grade arrhythmias,
• severe valvular heart disease,
• severe asthma or chronic obstructive lung disease,
• diabetes requiring insulin,
• musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training,
• a major psychiatric disorder,
• a history of drug abuse,
• alcohol consumption >14 drinks/week,
• gastric bypass surgery,
• non-English speaking, or
• a life-limiting comorbid medical condition (e.g. cancer).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Time restricted eating; 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.	Behavioral: Time restricted eating; Participants will work with a psychologist towards achieving a 16 hour fasting period, 2-3 days per week. The intervention will last 12 weeks, with different intervention materials gradually introduced over the course of the 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Memory Composite Rank	Participants completed two assessments of learning and memory at each time point. The Hopkins Verbal Learning Test Revised (HVLT-R) was used to assess verbal memory and the Brief Visual Memory Test - Revised (BVMT-R) was used to assess visual memory. Both the HVLT-R and the BVMT-R provide three separate scores that reflect total learning, retention of information, and recognition of learned items following a delay. In order to create a single Memory performance score, each of these six scores were ranked at each time point and a mean rank was created, with higher scores reflecting higher Memory performance. The mean rank for Memory performance at 12 weeks was used as the outcome, controlling for baseline Memory performance. Larger mean ranks at 12 weeks indicate greater improvements. As a rank-based outcome, values have no fixed theoretical upper or lower bound.	Baseline, 12 Weeks
Change in Executive Function Composite Rank	Participants underwent multiple assessments of Executive Functioning at each time point. Specifically, participants completed the Trail Making Test Parts A & B, the Digit Span Forwards and Backwards Tasks, the Digit Symbol Substitution Test, the Controlled Oral Word Association Test, the Animal Naming Test, and the Stroop Word and Color-Word Interference Tests at both pre-and-post treatment. In order to create a single Executive Function score, each of these nine measures were ranked at each time point and a mean rank was created, with higher scores reflecting higher Executive Function performance. The mean rank for Executive Function performance at 12 weeks was used as the outcome, controlling for baseline Executive Function performance, with larger 12-week mean ranks indicating greater improvements compared to baseline. As a rank-based outcome, values have no fixed theoretical upper or lower bound.	Baseline, 12 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Metabolic Function Composite Rank	Participants underwent assessments of multiple metabolic markers at each time point. Metabolic biomarkers included glucose, β-hydroxybutyrate, adiponectin, lactate, leptin, non-esterified fatty acids (NEFAs), and fibroblast growth factor-21. In order to create a single measure of Metabolic Function, each of these seven metabolic biomarkers were ranked at each time point and a mean rank was created, with higher scores reflecting better Metabolic Function. The mean rank for Metabolic Function at 12 weeks was used as the outcome, controlling for baseline Metabolic Function. If time restricted fasting was effective in improving Metabolic Function, then the mean rank composite score should be larger at 12 weeks compared to baseline. As a rank-based outcome,values have no fixed theoretical upper or lower bound.	Baseline, 12 Weeks
Change in Inflammatory Function Composite Rank	Participants underwent assessments of multiple inflammatory markers at each time point. Inflammatory biomarkers included interleukin-6, high-sensitivity C-reactive protein, vascular cell adhesion molecule, intracellular adhesion molecule, interleukin-10, tumor necrosis factor-alpha, tumor necrosis factor receptor type I, and tumor necrosis factor receptor type II. In order to create a single measure of Inflammatory Function, each of these seven inflammatory biomarkers were ranked at each time point and a mean rank was created, with higher scores reflecting higher Inflammatory Function. The mean rank for Inflammatory Function at 12 weeks was used as the outcome, controlling for baseline Inflammatory Function. Smaller values at 12 weeks compared to baseline were indicative of reduced inflammation. As a rank-based outcome, values have no fixed theoretical upper or lower bound.	Baseline, 12 Weeks

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: Duke University; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Patrick J Smith, PhD, MPH, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): August 7, 2023
• Primary Completion (Actual): June 26, 2025
• Study Completion (Actual): June 26, 2025

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 5, 2026
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nutrition Disorders; Overnutrition; Body Weight; Neurocognitive Disorders; Cognition Disorders; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Cognitive Dysfunction
• Other Study ID Numbers: 22-2774; 1R61AG080615-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We will submit de-identified study data to a public database in accordance with the NIH data sharing policy. Datasets will be prepared and submitted to the appropriate program officer no later than 3 years after all patient follow up is complete or 2 years after main manuscript publication of study results (whichever comes first). Dr. Smith will also include documentation and key study documents such as protocol, electronic case report forms, manuals of procedures, and applicable training materials to enable the use of prepared data sets by outside investigators. Data sets and associated documentation will be provided in the preferred electronic format. The prepared and submitted data set will include at minimum baseline, interim visit, procedural and intervention based data, and outcomes data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No