Time Restricted Eating for Metabolic and Psychological Optimization

NCT05997316 | Completed Results DMC

• 2 other identifiers: 22-27741R61AG080615-01
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mild Cognitive Impairment; Obesity

Outcome Measures

Primary Outcomes (2)

• 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. If time restricted fasting was effective in improving Memory performance, then the mean rank composite score should be larger at 12 weeks compared to baseline.

  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. If time restricted fasting was effective in improving Executive Function performance, then the mean rank composite score should be larger at 12 weeks compared to baseline.

  Baseline, 12 Weeks

Secondary Outcomes (2)

• Change in Metabolic Function Composite Rank

  Baseline, 12 Weeks

• Change in Inflammatory Function Composite Rank

  Baseline, 12 Weeks

Study Arms (1)

Time restricted eating

EXPERIMENTAL

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

Interventions

Time restricted eating BEHAVIORAL

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.

Time restricted eating

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Duke University: collaborator
• National Institute on Aging (NIA): collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina

Chapel Hill, North Carolina, 27519, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Obesity

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Patrick J. Smith, PhD, MPH
• Organization: University of North Carolina at Chapel Hill

patrick_smith@med.unc.edu

919-966-9812

Study Officials

• Patrick J Smith, PhD, MPH

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Assessors will be blinded to the participant's intervention fidelity and engagement.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2023
• First Posted: August 18, 2023
• Study Start: August 7, 2023
• Primary Completion: June 26, 2025
• Study Completion: June 26, 2025
• Last Updated: March 27, 2026
• Results First Posted: March 27, 2026

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)