Age-related Cognitive DeclineNCT04938778
Think FAST Research Study
A study testing PNF in people with Age-related Cognitive Decline, run by Arizona State University at 1 site in United States.
Trial summary
To test a 14-hour prolonged nightly fasting (PNF) protocol in a group of older adults (≥ 65 years old) with self-identified age-related cognitive decline (ARCD) on the primary outcome of neurocognitive function and performance as measured by objective outcomes. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Age-related Cognitive Decline
- What is being tested?
- PNF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 30 Jul 2022
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- 65 or older
- Self-identified age-related cognitive decline (ARCD)
- Has a text capable phone and access to wifi
Who cannot join
- Diagnosed with an eating disorder in the past 20 years
- Works a night shift
- Cannot participate in a 14 hour fast
- Has diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prolonged Nightly Fasting (PNF) in Older Adults With Age-related Cognitive Decline: A Pilot Study Exploring Changes in Neurocognitive Function (Public Name:Think FAST)
To test a 14-hour prolonged nightly fasting (PNF) protocol in a group of older adults (≥ 65 years old) with self-identified age-related cognitive decline (ARCD) on the primary outcome of neurocognitive function and performance as measured by objective outcomes. The investigators will use an 8-week single group pre-post pilot study design to measure outcomes related to neurocognitive function and performance and cardiometabolic risk factors (i.e., sleep disturbances, body mass index).
- Conditions
- Age-related Cognitive Decline
- Being tested
- PNF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PNFOther
PNF Participants will engage in 8 weeks of 14 hours per night fasting
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | 8 week 14 hour prolonged nightly fasting intervention. Receives: Other: PNF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory and Attention Phone Screener (MAPS)
Cognitive Function and Performance Test.
Measured: 8 weeks
Secondary outcomes (6)
Rapid Eating Assessment for Participants Scale (REAPS)
Scale to asses eating behaviors. The scale has a minimum of 13 and a maximum of 39. Higher scores indicate higher diet quality.
Measured: 8 weeks
Insomnia Severity Index (ISI)
Scale to asses insomnia symptoms. The scale has a minimum of zero and maximum of 28 where zero would be absence of insomnia and 28 would be severe insomnia.
Measured: 8 weeks
Mindful Eating Scale (MES)
Scale to asses behaviors related to mindful eating. Each item has a minimum of zero and a maximum of 4 where 4 means less eating awareness.
Measured: 8 weeks
Creature of Habit Scale (COHS)
Scale to asses routine habits. Each item has a minimum of zero and a maximum of 4 where 4 means a more habitual nature.
Measured: 8 weeks
Salivary Cortisol
Measure of cortisol via participant saliva samples.
Measured: 8 weeks
Body Mass Index (BMI)
Self-reported body measurements .
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start1 Feb 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Cognitive DeclineStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arizona State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Darith James, Arizona State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04938778
- Sponsor's protocol ID
- 00012888
- Status last verified
- Aug 2022
- First submitted
- 10 Mar 2021
- Last updated
- 4 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prolonged Nightly Fasting (PNF) in Older Adults With Age-related Cognitive Decline: A Pilot Study Exploring Changes in Neurocognitive Function (Public Name:Think FAST)
- ClinicalTrials.gov ID
- NCT04938778
- Acronym / sponsor ID
- 00012888
- Conditions
- Age-related Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Arizona State UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 24 Jun 2021 (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.
To test a 14-hour prolonged nightly fasting (PNF) protocol in a group of older adults (≥ 65 years old) with self-identified age-related cognitive decline (ARCD) on the primary outcome of neurocognitive function and performance as measured by objective outcomes. The investigators will use an 8-week single group pre-post pilot study design to measure outcomes related to neurocognitive function and performance and cardiometabolic risk factors (i.e., sleep disturbances, body mass index).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Other: PNF8 week 14 hour prolonged nightly fasting intervention. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 65 or older
- Self-identified age-related cognitive decline (ARCD)
- Has a text capable phone and access to wifi
Key exclusion criteria (4 listed)
- Diagnosed with an eating disorder in the past 20 years
- Works a night shift
- Cannot participate in a 14 hour fast
- Has diabetes
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 |
|---|---|---|
| PNFPNF Participants will engage in 8 weeks of 14 hours per night fasting | Other | Intervention Arm |
Primary outcome
Memory and Attention Phone Screener (MAPS)
Time frame: 8 weeks
Cognitive Function and Performance Test.
6 secondary outcomes
Rapid Eating Assessment for Participants Scale (REAPS)
Time frame: 8 weeks
Insomnia Severity Index (ISI)
Time frame: 8 weeks
Mindful Eating Scale (MES)
Time frame: 8 weeks
Creature of Habit Scale (COHS)
Time frame: 8 weeks
Salivary Cortisol
Time frame: 8 weeks
Body Mass Index (BMI)
Time frame: 8 weeks
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 4 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PNF in people with Age-related Cognitive Decline, run by Arizona State University 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 3 inclusion and 4 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 4 Aug 2022. 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?
Memory and Attention Phone Screener (MAPS) (time frame: 8 weeks). 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 4 Aug 2022.