Mild Cognitive ImpairmentTEMPONCT05997316
Time Restricted Eating for Metabolic and Psychological Optimization
A study testing Time restricted eating in people with Mild Cognitive Impairment and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Obesity
- What is being tested?
- Time restricted eating
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2023to 26 Jun 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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,
Show all 15Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27519
About this study
Official title: Assessing the Feasibility and Acceptability of a Time Restricted Feeding Intervention Among Older Adults With Mild Cognitive Impairment
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.
Read the 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'.
- Conditions
- Mild Cognitive Impairment, Obesity
- Being tested
- Time restricted eating
- Medical subject headings
- Cognitive Dysfunction, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time restricted eatingBehavioural
Participants will work with a psychologist towards achieving a 16 hour fasting period, 2-3 days per week. The intervention will last 12 weeks, with different intervention materials gradually introduced over the course of the 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating | Experimental | 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. Receives: Behavioral: Time restricted eating |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Memory Composite Rank
Participants completed two assessments of learning and memory at each time point. The Hopkins Verbal Learning Test Revised (HVLT-R) was used to assess verbal memory and the Brief Visual Memory Test - Revised (BVMT-R) was used to assess visual memory. Both the HVLT-R and the BVMT-R provide three separate scores that reflect total learning, retention of information, and recognition of learned items following a delay. In order to create a single Memory performance score, each of these six scores were ranked at each time point and a mean rank was created, with higher scores reflecting higher Memory performance. The mean rank for Memory performance at 12 weeks was used as the outcome, controlling for baseline Memory performance. Larger mean ranks at 12 weeks indicate greater improvements. As a rank-based outcome, values have no fixed theoretical upper or lower bound.
Measured: Baseline, 12 Weeks
Change in Executive Function Composite Rank
Participants underwent multiple assessments of Executive Functioning at each time point. Specifically, participants completed the Trail Making Test Parts A \& B, the Digit Span Forwards and Backwards Tasks, the Digit Symbol Substitution Test, the Controlled Oral Word Association Test, the Animal Naming Test, and the Stroop Word and Color-Word Interference Tests at both pre-and-post treatment. In order to create a single Executive Function score, each of these nine measures were ranked at each time point and a mean rank was created, with higher scores reflecting higher Executive Function performance. The mean rank for Executive Function performance at 12 weeks was used as the outcome, controlling for baseline Executive Function performance, with larger 12-week mean ranks indicating greater improvements compared to baseline. As a rank-based outcome, values have no fixed theoretical upper or lower bound.
Measured: Baseline, 12 Weeks
Secondary outcomes (2)
Change in Metabolic Function Composite Rank
Participants underwent assessments of multiple metabolic markers at each time point. Metabolic biomarkers included glucose, β-hydroxybutyrate, adiponectin, lactate, leptin, non-esterified fatty acids (NEFAs), and fibroblast growth factor-21. In order to create a single measure of Metabolic Function, each of these seven metabolic biomarkers were ranked at each time point and a mean rank was created, with higher scores reflecting better Metabolic Function. The mean rank for Metabolic Function at 12 weeks was used as the outcome, controlling for baseline Metabolic Function. If time restricted fasting was effective in improving Metabolic Function, then the mean rank composite score should be larger at 12 weeks compared to baseline. As a rank-based outcome,values have no fixed theoretical upper or lower bound.
Measured: Baseline, 12 Weeks
Change in Inflammatory Function Composite Rank
Participants underwent assessments of multiple inflammatory markers at each time point. Inflammatory biomarkers included interleukin-6, high-sensitivity C-reactive protein, vascular cell adhesion molecule, intracellular adhesion molecule, interleukin-10, tumor necrosis factor-alpha, tumor necrosis factor receptor type I, and tumor necrosis factor receptor type II. In order to create a single measure of Inflammatory Function, each of these seven inflammatory biomarkers were ranked at each time point and a mean rank was created, with higher scores reflecting higher Inflammatory Function. The mean rank for Inflammatory Function at 12 weeks was used as the outcome, controlling for baseline Inflammatory Function. Smaller values at 12 weeks compared to baseline were indicative of reduced inflammation. As a rank-based outcome, values have no fixed theoretical upper or lower bound.
Measured: Baseline, 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start7 Aug 2023
- Primary completion26 Jun 2025
- Study completion26 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Duke University, National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Patrick J Smith, PhD, MPH, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997316
- Sponsor's protocol ID
- 22-2774
- Other IDs
- 1R61AG080615-01
- Acronym
- TEMPO
- Status last verified
- Aug 2025
- First submitted
- 10 Aug 2023
- Last updated
- 24 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: We will submit de-identified study data to a public database in accordance with the NIH data sharing policy. Datasets will be prepared and submitted to the appropriate program officer no later than 3 years after all patient follow up is complete or 2 years after main manuscript publication of study results (whichever comes first). Dr. Smith will also include documentation and key study documents such as protocol, electronic case report forms, manuals of procedures, and applicable training materials to enable the use of prepared data sets by outside investigators. Data sets and associated documentation will be provided in the preferred electronic format. The prepared and submitted data set will include at minimum baseline, interim visit, procedural and intervention based data, and outcomes data.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Feasibility and Acceptability of a Time Restricted Feeding Intervention Among Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT05997316
- Acronym / sponsor ID
- TEMPO / 22-2774
- Conditions
- Mild Cognitive Impairment, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Duke University, National Institute on Aging (NIA)
- Study start
- 7 Aug 2023 (actual)
- Primary completion
- 26 Jun 2025 (actual)
- Study completion
- 26 Jun 2025 (actual)
- First posted
- 18 Aug 2023 (actual)
- Results
- Posted 27 Mar 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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'.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Experimental | Behavioral: Time restricted eatingParticipants 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. |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (15 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time restricted eatingParticipants will work with a psychologist towards achieving a 16 hour fasting period, 2-3 days per week. The intervention will last 12 weeks, with different intervention materials gradually introduced over the course of the 12 weeks. | Behavioural | Time restricted eating |
Primary outcome
Change in Memory Composite Rank
Time frame: Baseline, 12 Weeks
Participants completed two assessments of learning and memory at each time point. The Hopkins Verbal Learning Test Revised (HVLT-R) was used to assess verbal memory and the Brief Visual Memory Test - Revised (BVMT-R) was used to assess visual memory. Both the HVLT-R and the BVMT-R provide three separate scores that reflect total learning, retention of information, and recognition of learned items following a delay. In order to create a single Memory performance score, each of these six scores were ranked at each time point and a mean rank was created, with higher scores reflecting higher Memory performance. The mean rank for Memory performance at 12 weeks was used as the outcome, controlling for baseline Memory performance. Larger mean ranks at 12 weeks indicate greater improvements. As a rank-based outcome, values have no fixed theoretical upper or lower bound.
Change in Executive Function Composite Rank
Time frame: Baseline, 12 Weeks
Participants underwent multiple assessments of Executive Functioning at each time point. Specifically, participants completed the Trail Making Test Parts A \& B, the Digit Span Forwards and Backwards Tasks, the Digit Symbol Substitution Test, the Controlled Oral Word Association Test, the Animal Naming Test, and the Stroop Word and Color-Word Interference Tests at both pre-and-post treatment. In order to create a single Executive Function score, each of these nine measures were ranked at each time point and a mean rank was created, with higher scores reflecting higher Executive Function performance. The mean rank for Executive Function performance at 12 weeks was used as the outcome, controlling for baseline Executive Function performance, with larger 12-week mean ranks indicating greater improvements compared to baseline. As a rank-based outcome, values have no fixed theoretical upper or lower bound.
2 secondary outcomes
Change in Metabolic Function Composite Rank
Time frame: Baseline, 12 Weeks
Change in Inflammatory Function Composite Rank
Time frame: Baseline, 12 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. We will submit de-identified study data to a public database in accordance with the NIH data sharing policy. Datasets will be prepared and submitted to the appropriate program officer no later than 3 years after all patient follow up is complete or 2 years after main manuscript publication of study results (whichever comes first). Dr. Smith will also include documentation and key study documents such as protocol, electronic case report forms, manuals of procedures, and applicable training materials to enable the use of prepared data sets by outside investigators. Data sets and associated documentation will be provided in the preferred electronic format. The prepared and submitted data set will include at minimum baseline, interim visit, procedural and intervention based data, and outcomes data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick J Smith, PhD, MPH principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time restricted eating in people with Mild Cognitive Impairment and Obesity, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Memory Composite Rank (time frame: Baseline, 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.