Time Restricted Eating for Metabolic and Psychological Optimization

NCT ID: NCT05997316

Last Updated: 2025-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-07
• Study Completion Date: 2025-06-26

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.

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'.

Conditions

Mild Cognitive Impairment; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Time restricted eating

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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; and score of > 1.0 on the Mail-in Cognitive Function Screening Instrument),
• obese (body mass index 30-40 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).

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J Smith, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina

Chapel Hill, North Carolina, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

1R61AG080615-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-2774

Identifier Type: -

Identifier Source: org_study_id