Time Restricted Eating
Conditions
Keywords
Time restricted eating, Intermittent fasting, neurovascular coupling, cognitive function, aging
Brief summary
The central hypothesis of this study is that closer adherence to time restricted eating (TRE) will improve endothelial function, neurovascular (NVC) responses, resulting in improved cognitive performance, potentially through activation of SIRT1-dependent vasoprotective pathways.
Detailed description
This hypothesis will be tested by assessing the effect of TRE (not more than 10hr eating window each day for 6 months) in healthy adults (≥21 years of age).
Interventions
BEHAVIORALTime restricted eating
14:10 daily fasting regimen
Sponsors
University of Oklahoma
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥21 years * Adequate hearing and visual acuity to participate in examinations * Ability to read and write in English * Competence to provide informed consent
Exclusion criteria
* Vision or hearing impairment that would impair the ability to complete study assessments * Active CNS disease including multiple sclerosis, uncontrolled seizures, and active brain cancer * Cerebrovascular accident other than TIA within 60 days prior to screening * Any other medical condition which, in the opinion of the investigator, would render the participant inappropriate or too unstable to complete the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Neurovascular Coupling Using Functional Near Infrared Spectroscopy (fNIRS) | Baseline, 6 months | Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated hemoglobin measured over the cortical brain tissues. fNIRS data is analyzed using a pipeline based on the General Linear Model (GLM) approach created using the Brain AnalyzIR toolbox and implemented in MatLab. At the subject level, regression coefficients (beta values) are extracted to characterize individual neurovascular coupling response in the prefrontal cortex across all n-back blocks. It is expected that more difficult cognitive tasks will lead to increased neurovascular coupling responses in healthy individuals, but no clinically relevant ranges exist for this measure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neurovascular Coupling Using the Dynamic Retinal Vessel Analysis | Baseline, 6 months | Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). The change in retinal vessel diameters is tracked and reported as a %change from baseline, before and after treatment. |
| Neurovascular Coupling Using Transcranial Doppler | Baseline, 6 months | Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment. |
| Microvascular Endothelial Function | Baseline, 6 months | Changes in microvascular endothelial function will be assessed using laser speckle contrast imaging (LSCI) in the hand using the flow mediated dilation approach. The change in skin perfusion is calculated and reported as a fold change from baseline. |
| Macrovascular Endothelial Function | Baseline, 6 months | Changes in macrovascular endothelial function will be assessed using sonography during flow mediated dilation approach. The change in brachial artery diameter is calculated and reported as a %change from baseline. |
| Deep Tissue Oxygen Saturation | Baseline, 6 months | Transcutaneous deep tissue oxygen saturation will be measured using the inSpectra near infrared device. The data are calculated and reported as a %change from baseline. |
| Arterial Stiffness | Baseline, 6 months | The arterial stiffness will be measured using the pulse wave analysis approach (SphygmoCor, Atcor medical, Itasca IL, or similar). Analysis generated the augmentation index which will be used for comparison before and after treatment. |
| ECG | Baseline, 6 months | ECG will be recorded for heart rate variability analysis. The values of high frequency domain, low frequency domain, their ratio, as well as total power will be calculated and used for comparison before and after treatment. |
| Glycocalyx - Perfused Boundary Region | Baseline, 6 months | Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include perfused boundary region (um), and will be used for comparison before and after treatment. |
| Capillary Density | Baseline, 6 months | Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include capillary density (mm/mm\^2), and will be used for comparison before and after treatment. |
| Red Blood Cell Velocity | Baseline, 6 months | Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include red blood cell velocity (um/sec), and will be used for comparison before and after treatment. |
| Inhibitory Control and Attention | Baseline, 6 months | Flanker Inhibitory Control and Attention Test was used to assess inhibitory control and attention. The participant is asked to focus on a particular stimulus while inhibiting attention to the stimuli flanking it. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes. |
| Episodic Memory | Baseline, 6 months | Picture Sequence Memory Test was used to assess episodic memory. Participants are shown a number of activities, and then asked to reproduce the sequence of pictures as it was presented to them. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes. |
| Working Memory | Baseline, 6 months | List Sorting Working Memory Test was used to assess working memory. The participant is asked to recall and sequence different stimuli that are presented visually and via audio. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes. |
| Language | Baseline, 6 months | Picture Vocabulary Test measures receptive vocabulary administered in a computer-adaptive test (CAT) format. Respondents select the picture that most closely matches the meaning of the word. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes. |
| Executive Function | Baseline, 6 months | Dimensional Change Card Sort Test was used to assess cognitive flexibility and attention. The participant is asked to match a series of picture pairs to a target picture. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes. |
| Processing Speed | Baseline, 6 months | Pattern Comparison Processing Speed Test was used to assess processing speed. Participants are asked to quickly determine whether two stimuli are the same or not the same. Scores are fully adjusted to nationally representative normative sample of NIH toolbox test takers, accounting for age, sex, race, and education (mean = 50; SD = 10). Higher scores represent better outcomes. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStefano Tarantini, PhD
University of Oklahoma
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants |
| Age, Continuous | 53.6 Years STANDARD_DEVIATION 8 |
| BMI | 30.3 kg/m^2 STANDARD_DEVIATION 6.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Godin Leisure-Time Exercise Questionnaire Active | 9 Participants |
| Godin Leisure-Time Exercise Questionnaire Insufficiently Active/Sedentary | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 11 |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
None listed