Clinical trial NCT05997316: Time Restricted Eating for Metabolic and Psychological Optimization
Official title: Assessing the Feasibility and Acceptability of a Time Restricted Feeding Intervention Among Older Adults With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Obesity
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Duke University
name: National Institute on Aging (NIA)
First posted: 2023-08-18
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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'.

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).

Primary outcomes:
measure: Memory
timeFrame: Baseline and 12 Weeks
measure: Executive Function
timeFrame: Baseline and 12 Weeks
Secondary outcomes:
measure: Metabolic Flexibility
timeFrame: Baseline and 12 Weeks
measure: Inflammatory Function
timeFrame: Baseline and 12 Weeks
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Patrick J Smith, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: