Overweight and ObesityNCT05732935

Fasting ENHANCE Pilot Study

A study testing Time Restricted Eating intervention and Successful Aging Comparison Group (LEARN) in people with Overweight and Obesity and Time Restricted Feeding, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Overweight and Obesity, Time Restricted Feeding, Alzheimer Disease
What is being tested?: Time Restricted Eating intervention and Successful Aging Comparison Group (LEARN)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited States
Study dates: 13 Mar 2023to 1 May 2026
Phase: Interventional
Are there results?: None posted in the registry

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 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Age ≥ 65 years;
Body Mass Index (BMI > 25 kg/m2)
Normal age-, gender-, and education-adjusted performance on TICS-M (Telephone Interview for Cognitive Status)
Responds yes to questions 1 (memory worse), 2 (word finding difficulties) or 3 (planning/organization difficulties) on the Subjective Cognitive Decline Questionnaire
Reports onset of cognitive difficulties in past five years
Reports they believe they are worse than others their age OR they have talked to a clinician about it.
Provides informed consent and willing to be randomized to either intervention group.

Who cannot join

Failure to provide informed consent;
Recent History or clinical manifestation of cardiovascular disease, diabetes, cholelithiasis, liver or renal disease, cancer, or progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels, or hemoglobin and hematocrit below the lower limit of normal) as determined by study physician.
Significant cognitive impairment, defined as a scores below the cutoff for dementia on TICS-M
Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory disease);
Terminal illness with life expectancy less than 12 months, as determined by a physician;

Show all 24Show fewer

Other significant co-morbid disease (e.g. renal failure on hemodialysis) or severe psychiatric disorder (e.g. bipolar, schizophrenia);
Current use of anabolic medications (i.e., growth hormones or testosterone), antidepressant medications, antipsychotic agents, monoamine oxidase inhibitors, anticholinesterase inhibitors (i.e., Aricept), anticoagulant therapies (aspirin use is permitted), or antibiotics;
Excessive alcohol use (>14 drinks per week);
History of drug or alcohol abuse (i.e., more than 5 drinks/day for males or more than 4 drinks/day for females);
Planning to permanently leave the area in the next year;
History of pulmonary disease, pneumonitis or interstitial lung disease;
Current smoker or less than 3 years quit;
Creatinine clearance < 30 ml/minute by estimated Glomerular Filtration Rate (eGFR);
Fasting >12 hours per day
Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake or weight loss > 5 lbs in the past month
Resting heart rate of >120 beats per minute, systolic blood pressure > 180 mmHg or diastolic blood pressure of > 100 mmHg
Unstable angina, heart attack or stroke in the past 3 months
Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure
Rheumatoid arthritis, Parkinson's disease or currently on dialysis
Insulin dependent diabetes mellitus
Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)
Participating in another clinical trial or has received an investigational product within 30 days prior to screening/enrollment
Any condition that in the opinion of the investigator would impair ability to participate in the trial.

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical and Translational Research Building - Institute on Aging Suite
Gainesville, Florida, 32603

Other trials in United States

About this study

Official title: Fasting to Provide Energy Needed to Help Adults in Need of Cognitive Enhancement (FASTING ENHANCE)

Grounded in the principles of geroscience, the proposed Fasting ENHANCE study will test whether a time restricted eating (TRE) regimen can improve cognitive function and other aspects of successful aging in a safe and sustainable manner in at risk overweight older adults. Specifically, this study will evaluate whether TRE can improve cognitive and physical function, as well as self-reported sleep, mood, and quality of life, in overweight, older adults (age > 65 years) who are at high risk of cognitive decline due to self-reported cognitive difficulties. Eligible participants will be assigned to either a TRE intervention, in which they will be instructed to fast for a target of 16 hours per day, or a successful aging (SA) comparison group for a 24-week period.

Read the detailed description

During the past century, persons aged >70 years represented the fastest growing segment of the US population with the life expectancy of older Americans steadily increasing, until the onset of COVID-19 in 2020. Unfortunately, the increase in lifespan has not been accompanied by an increase in health-span, which is the time-period in which a person is healthy and functionally independent. Rather, the aging population has been accompanied by an increase in the number of individuals living with chronic metabolic and neurocognitive disease conditions, including obesity, metabolic syndrome, and Alzheimer's disease and Related Disorders (ADRD). Moreover, poor metabolic health appears to be a risk factor for accelerated brain aging; therefore improving metabolic health may represent a strategy to improve long-term brain health.

Although age-related biological and metabolic changes clearly have a role in the development of chronic health conditions and risk for ADRD, a growing body of research indicates lifestyle factors contribute to modifiable patho-physiological states that precede the development of many age-related chronic health conditions. Specifically, over-nutrition, sedentary lifestyle, and poor sleep habits have been directly linked with metabolic diseases, as well as cognitive decline and development of ADRD in later life.

Our work and that of others has demonstrated that the rate of functional decline among older adults is highly influenced by biological and metabolic changes during aging, which are largely affected by lifestyle factors, namely dietary intake, sleep, and physical activity levels. Specifically, the investigators have shown that intermittent fasting (IF) regimens, particularly time restricted eating (TRE), can have positive effects on biological, metabolic, and functional health markers in middle-aged and older adults, similar to that of calorie restriction. These observations raise the possibility that interventions targeting the fundamental biology of human aging have the potential to delay, if not prevent, the onset of aging-associated conditions, such as ADRD. The unprecedented growth of the aging population has created an urgent need for promising interventions that can preserve older adult's capacity to live independently and function well.

The scientific premise of this proposal is that a time-restricted eating intervention can target the cellular and metabolic alterations that underlie age-related metabolic and neurocognitive disease conditions and thereby extend health-span in the growing population of older adults who reported subjective cognitive decline.

Conditions: Overweight and Obesity, Time Restricted Feeding, Alzheimer Disease
Being tested: Time Restricted Eating intervention, Successful Aging Comparison Group (LEARN)
Keywords: Aging, Time Restricted Eating, Overweight, Obesity, Alzheimer's Disease and Related Disorders (ADRD)
Medical subject headings: Overweight, Obesity, Intermittent Fasting, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Time Restricted Eating interventionBehavioural
Also called TRE intervention
In the TRE intervention, participants will be asked to fast for a target of 16 hours per day for a period of 24 weeks. The first few weeks will involve of a ramp up to a full 16-hour fasting period (Week 1 - fast for 12-14 hours per day, Week 2 - fast for 14-16 hours per day, Week 3 - 16 - fast for 16 hours per day). Participants will be allowed to consume calorie-free beverages, tea, black coffee, sugar-free gum, and they will be encouraged to drink plenty of water throughout the entire intervention period. Participants will be asked to record the time of first and final food/drink consumption each day.
Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.
Successful Aging Comparison Group (LEARN)Behavioural
In the Successful Aging Comparison Group (LEARN), participants will attend lectures on topic relevant to healthy aging at the same frequency as the group meetings in the TRE intervention.
Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.

Study groups in NCT05732935
Study group	Role	What they receive
Time Restricted Eating intervention	Experimental	In the time restricted eating condition, participants will be instructed to fast for a target of 16 hours per day for a 24 week period. Receives: Behavioral: Time Restricted Eating intervention
Successful Aging Comparison Group (LEARN)	Active comparator	In the LEARN group, participants will be educated on health related topics similar to that of the TRE intervention for 24 weeks. Receives: Behavioral: Successful Aging Comparison Group (LEARN)

What is being measured

The primary outcome is the main question the study is designed to answer.

Repeatable Battery of the Assessment of Neuropsychological Status (RBANS)
The RBANS is a neuropsychological battery of tests that has 4 repeatable forms that can be used longitudinally to measure cognitive change. It takes 30 minutes to administer and includes measures of five cognitive domains including immediate memory, visuospatial/constructional, language, attention, and delayed memory. This test is reliable in yielding results that recognize cognitive impairment associated with neurodegenerative disease. The RBANS can be used in predicting cognitive impairment with particular emphasis on the language and immediate memory subtests.
Measured: Baseline up to Week 24

Secondary outcomes (11)

Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a 30-point assessment of mild cognitive impairment, which assesses the domains of attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. Different versions of the test are given at the three time points to avoid learning effects between repeated administrations of the test.
Measured: Baseline up to Week 24
6 Minute Walk Test
The 6 Minute Walk test measures the amount of distance the participant can complete on a standard walking course in six minutes without running or overexerting themselves. It has been found to be a valid and reliable measure of physical function in numerous studies.
Measured: Baseline up to Week 24
Short Physical Performance Battery (SPPB)
The SPPB will also be used to assess functional performance on different tasks including timed short distance walk, repeated chair stands, and a balance test.
Measured: Baseline up to Week 24
Grip Strength
Isometric grip strength, a commonly used measure of upper body skeletal function, will be assessed with a hand held dynamometer
Measured: 1st Day of Screening
Pittsburgh Sleep Quality Index
Sleep will be assessed by the Pittsburgh Sleep Quality Index, a self-report tool which consists of 19-item scale that provides seven component scores (ranges 0-3): (a) subjective sleep quality (very good to very bad), (b) sleep latency (≤15 to >60 minutes), (c) sleep duration (≥7 to <5 hours), (d) sleep efficiency (≥85% to <65% hours sleep/ hours in bed), (e) sleep disturbances (not during the past month to ≥3 times per week), (f) use of sleeping medications (none to ≥3 times a week), and (g) daytime dysfunction (not a problem to a very big problem) with a total global score ranging from 0 to 21.
Measured: Baseline up to Week 24
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
The State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA) was designed to assess cognitive and somatic symptoms of anxiety as they pertain to one's mood in the moment (state) and in general (trait). This measure has been validated in a sample of older adults.
Measured: Baseline up to Week 24
Geriatric Depression Scale
Symptoms of depression will be assessed by the Geriatric Depression Scale, a self-report questionnaire to measure depression in older adults.
Measured: Baseline up to Week 24
Short Form (SF) -12 Health Survey
This 12-item short form questionnaire assesses both mental and physical components of health-related quality of life. The SF-12 Health Survey assesses 8 general domains: physical activity limitation due to health problems, social activity limitation due to physical/emotional problems, daily role activity limitations due to physical health problems, body pain, general mental health, daily role activity limitation due to emotional problems, energy and fatigue, and general health perceptions.
Measured: Baseline up to Week 24
Pittsburgh Fatiguability Scale
The 26-item Pittsburgh Fatiguability Scale will be administered to measure perceived mental and physical fatigability. Questions are divided into 4 main categories: moderate to high-intensity activity (≥3.0 metabolic equivalents (METS), social activity, sedentary activity (≤1.5 METS), and lifestyle or light-intensity activity (1.6-2.9 METS). Higher scores suggest higher levels of perceived fatigability.
Measured: Baseline up to Week 24
Metabolic and Systemic biomarkers
Biomarkers of glucose regulation (HbA1C), systemic inflammation (C-reactive protein), and neurodegenerative diseases, Tau will be assessed. Samples will be measured in duplicate and the average of the two measures will be used for data analyses.
Measured: Baseline up to Week 24
Anthropometric Measurements.
Body weight will be measured following the removal of excess clothing and shoes with calibrated scales. Waist circumference is taken at the mid-point between the participant's lowest rib and the top of his/her hip bone.
Measured: 1st Day of Screening up to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Mar 20231 May 2026

First posted17 Feb 2023
Study start13 Mar 2023
Primary completion1 May 2026
Study completion1 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (90)Papers the sponsor has linked to this study.
Other trials for Overweight and ObesityStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
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: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants will be assigned to either a time restricted eating intervention, in which they will be instructed to fast for a target of 16 hours per day, or a successful aging (SA) comparison group for a 24-week period. This Study will examine the effects of TRE on changes in cognitive function, as assessed by the Repeatable Battery of the Assessment of Neuropsychological Status (RBANS), examine the effects of TRE on cognitive physical function, as assessed by the six-minute walk and short physical performance battery, and examine the effects of TRE on changes in mood, sleep patterns, metabolic function, and self-reported quality of life.
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05732935
Sponsor's protocol ID: IRB202202838
Other IDs: R21AG081667, PRO00048080
Status last verified: Jun 2026
First submitted: 11 Jan 2023
Last updated: 30 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Publications

Arias E, Xu J, Tejada-Vera B, Bastian B. U.S. State Life Tables, 2019. Natl Vital Stat Rep. 2021 Feb;70(18):1-18.
PubMed 35157570
Engin A. The Definition and Prevalence of Obesity and Metabolic Syndrome. Adv Exp Med Biol. 2017;960:1-17. doi: 10.1007/978-3-319-48382-5_1.
PubMed 28585193
Shin D, Kongpakpaisarn K, Bohra C. Trends in the prevalence of metabolic syndrome and its components in the United States 2007-2014. Int J Cardiol. 2018 May 15;259:216-219. doi: 10.1016/j.ijcard.2018.01.139. Epub 2018 Feb 19.
PubMed 29472026
Matthews KA, Xu W, Gaglioti AH, Holt JB, Croft JB, Mack D, McGuire LC. Racial and ethnic estimates of Alzheimer's disease and related dementias in the United States (2015-2060) in adults aged >/=65 years. Alzheimers Dement. 2019 Jan;15(1):17-24. doi: 10.1016/j.jalz.2018.06.3063. Epub 2018 Sep 19.
PubMed 30243772
Angoff R, Himali JJ, Maillard P, Aparicio HJ, Vasan RS, Seshadri S, Beiser AS, Tsao CW. Relations of Metabolic Health and Obesity to Brain Aging in Young to Middle-Aged Adults. J Am Heart Assoc. 2022 Mar 15;11(6):e022107. doi: 10.1161/JAHA.121.022107. Epub 2022 Mar 1.
PubMed 35229662
Mankowski RT, Aubertin-Leheudre M, Beavers DP, Botoseneanu A, Buford TW, Church T, Glynn NW, King AC, Liu C, Manini TM, Marsh AP, McDermott M, Nocera JR, Pahor M, Strotmeyer ES, Anton SD; LIFE Research Group. Sedentary time is associated with the metabolic syndrome in older adults with mobility limitations--The LIFE Study. Exp Gerontol. 2015 Oct;70:32-6. doi: 10.1016/j.exger.2015.06.018. Epub 2015 Jun 28.
PubMed 26130060
Borel AL. Sleep Apnea and Sleep Habits: Relationships with Metabolic Syndrome. Nutrients. 2019 Nov 2;11(11):2628. doi: 10.3390/nu11112628.
PubMed 31684029
Booth FW, Roberts CK, Thyfault JP, Ruegsegger GN, Toedebusch RG. Role of Inactivity in Chronic Diseases: Evolutionary Insight and Pathophysiological Mechanisms. Physiol Rev. 2017 Oct 1;97(4):1351-1402. doi: 10.1152/physrev.00019.2016.
PubMed 28814614
Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018 Nov;14(11):653-666. doi: 10.1038/s41582-018-0070-3.
PubMed 30291317
Barnard ND, Bush AI, Ceccarelli A, Cooper J, de Jager CA, Erickson KI, Fraser G, Kesler S, Levin SM, Lucey B, Morris MC, Squitti R. Dietary and lifestyle guidelines for the prevention of Alzheimer's disease. Neurobiol Aging. 2014 Sep;35 Suppl 2:S74-8. doi: 10.1016/j.neurobiolaging.2014.03.033. Epub 2014 May 14.
PubMed 24913896
Dhana K, Evans DA, Rajan KB, Bennett DA, Morris MC. Healthy lifestyle and the risk of Alzheimer dementia: Findings from 2 longitudinal studies. Neurology. 2020 Jul 28;95(4):e374-e383. doi: 10.1212/WNL.0000000000009816. Epub 2020 Jun 17.
PubMed 32554763
Anton SD, Cruz-Almeida Y, Singh A, Alpert J, Bensadon B, Cabrera M, Clark DJ, Ebner NC, Esser KA, Fillingim RB, Goicolea SM, Han SM, Kallas H, Johnson A, Leeuwenburgh C, Liu AC, Manini TM, Marsiske M, Moore F, Qiu P, Mankowski RT, Mardini M, McLaren C, Ranka S, Rashidi P, Saini S, Sibille KT, Someya S, Wohlgemuth S, Tucker C, Xiao R, Pahor M. Innovations in Geroscience to enhance mobility in older adults. Exp Gerontol. 2020 Dec;142:111123. doi: 10.1016/j.exger.2020.111123. Epub 2020 Oct 22.
PubMed 33191210
Anton SD, Woods AJ, Ashizawa T, Barb D, Buford TW, Carter CS, Clark DJ, Cohen RA, Corbett DB, Cruz-Almeida Y, Dotson V, Ebner N, Efron PA, Fillingim RB, Foster TC, Gundermann DM, Joseph AM, Karabetian C, Leeuwenburgh C, Manini TM, Marsiske M, Mankowski RT, Mutchie HL, Perri MG, Ranka S, Rashidi P, Sandesara B, Scarpace PJ, Sibille KT, Solberg LM, Someya S, Uphold C, Wohlgemuth S, Wu SS, Pahor M. Successful aging: Advancing the science of physical independence in older adults. Ageing Res Rev. 2015 Nov;24(Pt B):304-27. doi: 10.1016/j.arr.2015.09.005. Epub 2015 Oct 14.
PubMed 26462882
Wegman MP, Guo MH, Bennion DM, Shankar MN, Chrzanowski SM, Goldberg LA, Xu J, Williams TA, Lu X, Hsu SI, Anton SD, Leeuwenburgh C, Brantly ML. Practicality of intermittent fasting in humans and its effect on oxidative stress and genes related to aging and metabolism. Rejuvenation Res. 2015 Apr;18(2):162-72. doi: 10.1089/rej.2014.1624.
PubMed 25546413
Anton S, Leeuwenburgh C. Fasting or caloric restriction for healthy aging. Exp Gerontol. 2013 Oct;48(10):1003-5. doi: 10.1016/j.exger.2013.04.011. Epub 2013 Apr 29.
PubMed 23639403

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity

All Overweight and Obesity trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Fasting to Provide Energy Needed to Help Adults in Need of Cognitive Enhancement (FASTING ENHANCE)
ClinicalTrials.gov ID: NCT05732935
Acronym / sponsor ID: IRB202202838
Conditions: Overweight and Obesity, Time Restricted Feeding, Alzheimer Disease
Keywords: Aging, Time Restricted Eating, Overweight, Obesity, Alzheimer's Disease and Related Disorders (ADRD)
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Florida Department of Health, Ed and Ethel Moore Alzheimer's Disease Research Program
Study start: 13 Mar 2023 (actual)
Primary completion: 1 May 2026 (actual)
Study completion: 1 May 2026 (actual)
First posted: 17 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Participants will be assigned to either a time restricted eating intervention, in which they will be instructed to fast for a target of 16 hours per day, or a successful aging (SA) comparison group for a 24-week period. This Study will examine the effects of TRE on changes in cognitive function, as assessed by the Repeatable Battery of the Assessment of Neuropsychological Status (RBANS), examine the effects of TRE on cognitive physical function, as assessed by the six-minute walk and short physical performance battery, and examine the effects of TRE on changes in mood, sleep patterns, metabolic function, and self-reported quality of life.

Arm	Type	Receives
Time Restricted Eating intervention	Experimental	Behavioral: Time Restricted Eating interventionIn the time restricted eating condition, participants will be instructed to fast for a target of 16 hours per day for a 24 week period.
Successful Aging Comparison Group (LEARN)	Active comparator	Behavioral: Successful Aging Comparison Group (LEARN)In the LEARN group, participants will be educated on health related topics similar to that of the TRE intervention for 24 weeks.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (7 listed)

Age ≥ 65 years;
Body Mass Index (BMI > 25 kg/m2)
Normal age-, gender-, and education-adjusted performance on TICS-M (Telephone Interview for Cognitive Status)
Responds yes to questions 1 (memory worse), 2 (word finding difficulties) or 3 (planning/organization difficulties) on the Subjective Cognitive Decline Questionnaire
Reports onset of cognitive difficulties in past five years

Key exclusion criteria (24 listed)

Failure to provide informed consent;
Recent History or clinical manifestation of cardiovascular disease, diabetes, cholelithiasis, liver or renal disease, cancer, or progressive, degenerative neurologic disease (e.g., Parkinson's Disease, multiple sclerosis, ALS)
Abnormal laboratory markers (e.g., renal or liver abnormalities, elevated potassium levels, or hemoglobin and hematocrit below the lower limit of normal) as determined by study physician.
Significant cognitive impairment, defined as a scores below the cutoff for dementia on TICS-M
Severe rheumatologic or orthopedic diseases (e.g., awaiting joint replacement, active inflammatory 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 Eating interventionAlso: TRE interventionIn the TRE intervention, participants will be asked to fast for a target of 16 hours per day for a period of 24 weeks. The first few weeks will involve of a ramp up to a full 16-hour fasting period (Week 1 - fast for 12-14 hours per day, Week 2 - fast for 14-16 hours per day, Week 3 - 16 - fast for 16 hours per day). Participants will be allowed to consume calorie-free beverages, tea, black coffee, sugar-free gum, and they will be encouraged to drink plenty of water throughout the entire intervention period. Participants will be asked to record the time of first and final food/drink consumption each day. Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.	Behavioural	Time Restricted Eating intervention
Successful Aging Comparison Group (LEARN)In the Successful Aging Comparison Group (LEARN), participants will attend lectures on topic relevant to healthy aging at the same frequency as the group meetings in the TRE intervention. Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.	Behavioural	Successful Aging Comparison Group (LEARN)

Primary outcome

Repeatable Battery of the Assessment of Neuropsychological Status (RBANS)
Time frame: Baseline up to Week 24
The RBANS is a neuropsychological battery of tests that has 4 repeatable forms that can be used longitudinally to measure cognitive change. It takes 30 minutes to administer and includes measures of five cognitive domains including immediate memory, visuospatial/constructional, language, attention, and delayed memory. This test is reliable in yielding results that recognize cognitive impairment associated with neurodegenerative disease. The RBANS can be used in predicting cognitive impairment with particular emphasis on the language and immediate memory subtests.

11 secondary outcomes

Montreal Cognitive Assessment (MoCA)
Time frame: Baseline up to Week 24
6 Minute Walk Test
Time frame: Baseline up to Week 24
Short Physical Performance Battery (SPPB)
Time frame: Baseline up to Week 24
Grip Strength
Time frame: 1st Day of Screening
Pittsburgh Sleep Quality Index
Time frame: Baseline up to Week 24
State-Trait Inventory for Cognitive and Somatic Anxiety (STICSA)
Time frame: Baseline up to Week 24
Geriatric Depression Scale
Time frame: Baseline up to Week 24
Short Form (SF) -12 Health Survey
Time frame: Baseline up to Week 24
Pittsburgh Fatiguability Scale
Time frame: Baseline up to Week 24
Metabolic and Systemic biomarkers
Time frame: Baseline up to Week 24
Anthropometric Measurements.
Time frame: 1st Day of Screening up to Week 24

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
Background: PubMed 35157570Arias E, Xu J, Tejada-Vera B, Bastian B. U.S. State Life Tables, 2019. Natl Vital Stat Rep. 2021 Feb;70(18):1-18.
Background: PubMed 28585193Engin A. The Definition and Prevalence of Obesity and Metabolic Syndrome. Adv Exp Med Biol. 2017;960:1-17. doi: 10.1007/978-3-319-48382-5_1.
Background: PubMed 29472026Shin D, Kongpakpaisarn K, Bohra C. Trends in the prevalence of metabolic syndrome and its components in the United States 2007-2014. Int J Cardiol. 2018 May 15;259:216-219. doi: 10.1016/j.ijcard.2018.01.139. Epub 2018 Feb 19.
Background: PubMed 30243772Matthews KA, Xu W, Gaglioti AH, Holt JB, Croft JB, Mack D, McGuire LC. Racial and ethnic estimates of Alzheimer's disease and related dementias in the United States (2015-2060) in adults aged >/=65 years. Alzheimers Dement. 2019 Jan;15(1):17-24. doi: 10.1016/j.jalz.2018.06.3063. Epub 2018 Sep 19.
Background: PubMed 35229662Angoff R, Himali JJ, Maillard P, Aparicio HJ, Vasan RS, Seshadri S, Beiser AS, Tsao CW. Relations of Metabolic Health and Obesity to Brain Aging in Young to Middle-Aged Adults. J Am Heart Assoc. 2022 Mar 15;11(6):e022107. doi: 10.1161/JAHA.121.022107. Epub 2022 Mar 1.
Background: PubMed 26130060Mankowski RT, Aubertin-Leheudre M, Beavers DP, Botoseneanu A, Buford TW, Church T, Glynn NW, King AC, Liu C, Manini TM, Marsh AP, McDermott M, Nocera JR, Pahor M, Strotmeyer ES, Anton SD; LIFE Research Group. Sedentary time is associated with the metabolic syndrome in older adults with mobility limitations--The LIFE Study. Exp Gerontol. 2015 Oct;70:32-6. doi: 10.1016/j.exger.2015.06.018. Epub 2015 Jun 28.
Background: PubMed 31684029Borel AL. Sleep Apnea and Sleep Habits: Relationships with Metabolic Syndrome. Nutrients. 2019 Nov 2;11(11):2628. doi: 10.3390/nu11112628.
Background: PubMed 28814614Booth FW, Roberts CK, Thyfault JP, Ruegsegger GN, Toedebusch RG. Role of Inactivity in Chronic Diseases: Evolutionary Insight and Pathophysiological Mechanisms. Physiol Rev. 2017 Oct 1;97(4):1351-1402. doi: 10.1152/physrev.00019.2016.
Background: PubMed 30291317Kivipelto M, Mangialasche F, Ngandu T. Lifestyle interventions to prevent cognitive impairment, dementia and Alzheimer disease. Nat Rev Neurol. 2018 Nov;14(11):653-666. doi: 10.1038/s41582-018-0070-3.
Background: PubMed 24913896Barnard ND, Bush AI, Ceccarelli A, Cooper J, de Jager CA, Erickson KI, Fraser G, Kesler S, Levin SM, Lucey B, Morris MC, Squitti R. Dietary and lifestyle guidelines for the prevention of Alzheimer's disease. Neurobiol Aging. 2014 Sep;35 Suppl 2:S74-8. doi: 10.1016/j.neurobiolaging.2014.03.033. Epub 2014 May 14.
Background: PubMed 32554763Dhana K, Evans DA, Rajan KB, Bennett DA, Morris MC. Healthy lifestyle and the risk of Alzheimer dementia: Findings from 2 longitudinal studies. Neurology. 2020 Jul 28;95(4):e374-e383. doi: 10.1212/WNL.0000000000009816. Epub 2020 Jun 17.
Background: PubMed 33191210Anton SD, Cruz-Almeida Y, Singh A, Alpert J, Bensadon B, Cabrera M, Clark DJ, Ebner NC, Esser KA, Fillingim RB, Goicolea SM, Han SM, Kallas H, Johnson A, Leeuwenburgh C, Liu AC, Manini TM, Marsiske M, Moore F, Qiu P, Mankowski RT, Mardini M, McLaren C, Ranka S, Rashidi P, Saini S, Sibille KT, Someya S, Wohlgemuth S, Tucker C, Xiao R, Pahor M. Innovations in Geroscience to enhance mobility in older adults. Exp Gerontol. 2020 Dec;142:111123. doi: 10.1016/j.exger.2020.111123. Epub 2020 Oct 22.

Related trials for Overweight and Obesity

RecruitingPhase 4
Translational Health Research Into Vascular and Neurocognitive Effects of Weight Loss
Class I/II Obesity
Not yet recruitingObservational study
Assessing the Impact of Perceptions of Unpredictability on Objective Measures of Food Consumption and Metabolism
Healthy Volunteer, Obestity
RecruitingPhase 1/2
A Phase 1/2a Study of WVE-007 in Adults Living With Overweight or Obesity
Overweight and Obesity
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Not yet recruitingObservational study
A Natural History of Genetic and Environmental Predictors of Pubertal Timing Among Youth With Obesity
Obesity

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.

Stephen Anton, Ph.D. principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 7 inclusion and 24 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 30 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Repeatable Battery of the Assessment of Neuropsychological Status (RBANS) (time frame: Baseline up to Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05732935, which also lists 90 linked publications.

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 30 Jun 2026.