N/A
N=33
Time Restricted Eating for Metabolic and Psychological Optimization
Mild Cognitive Impairment · Obesity
Bottom Line
View on ClinicalTrials.gov: NCT05997316 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Mar 2026
Primary outcome: Primary: Change in Memory Composite Rank — 6.22 rank — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Time restricted eating (Behavioral)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jun 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Memory Composite Rank |
6.22 | <0.001 sig |
| PRIMARY Change in Executive Function Composite Rank |
5.97 | 0.017 sig |
| SECONDARY Change in Metabolic Function Composite Rank |
1.31 | 0.048 sig |
| SECONDARY Change in Inflammatory Function Composite Rank |
0.35 | 0.572 |
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.
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 or a phonemic fluency score of = 25) or semantic fluency score of = 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.
Exclusion Criteria
Reasons for participant exclusion will include:
- secondary causes of obesity,
- evidence of clinical dementia (MoCA score 14 drinks/week,
- gastric bypass surgery,
- non-English speaking, or
- a life-limiting comorbid medical condition (e.g. cancer).
Data sourced from ClinicalTrials.gov (NCT05997316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.