NCT05997316Completed
Time Restricted Eating for Metabolic and Psychological Optimization
Assessing the Feasibility and Acceptability of a Time Restricted Feeding Intervention Among Older Adults With Mild Cognitive Impairment
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 33 (actual)
- First submitted
- 10 Aug 2023
- Start date
- 7 Aug 2023
- Primary completion date
- 26 Jun 2025
- Lead sponsor
- University of North Carolina, Chapel Hill
- Diseases
- Obesity
- NCT number
- NCT05997316
What you commit to
- Study type: Interventional
- Participants enrolled: 33
- From 7 Aug 2023 to the primary completion date, 26 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- gastric bypass surgery,
Other illness
- heart failure,
- high grade arrhythmias,
- severe valvular heart disease,
- severe asthma or chronic obstructive lung disease,
- diabetes requiring insulin,
- a major psychiatric disorder,
- a history of drug abuse,
- a life-limiting comorbid medical condition (e.g. cancer).
Lab values
- evidence of clinical dementia (MoCA score \< 18), severe chronic kidney disease (eGFR \<45 ml/min/1.73m\^2),
Other
- Reasons for participant exclusion will include:
- secondary causes of obesity,
- musculoskeletal or neurologic problems that would preclude participation in aerobic exercise training,
- alcohol consumption \>14 drinks/week,
- non-English speaking, or
Who the study is looking for
- 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 =\<12 (with MoCA \>25) or semantic fluency score of =\<15 (with MoCA \>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.
Age in the registry: 65 years to 85 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.