Time Restricted Eating for Metabolic and Psychological Optimization (TEMPO)

University of North Carolina (UNC)

Status: Completed

Conditions: Mild Cognitive Impairment; Obesity

Treatments: Behavioral: Time restricted eating

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05997316

22-2774

1R61AG080615-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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'.

Enrollment: 33 patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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33 participants in 1 patient group

Time restricted eating

Experimental group

Description:

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:

Behavioral: Time restricted eating