Status:
COMPLETED
Time Restricted Eating for Metabolic and Psychological Optimization
Lead Sponsor:
University of North Carolina, Chapel Hill
Collaborating Sponsors:
Duke University
National Institute on Aging (NIA)
Conditions:
Mild Cognitive Impairment
Obesity
Eligibility:
All Genders
65-80 years
Phase:
NA
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). Dy...
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,...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 26 2025
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT05997316
Start Date
August 7 2023
End Date
June 26 2025
Last Update
September 4 2025
Active Locations (1)
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1
University of North Carolina
Chapel Hill, North Carolina, United States, 27519