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Think FAST Research Study

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ClinicalTrials.gov Identifier: NCT04938778
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : June 29, 2021
Sponsor:
Information provided by (Responsible Party):
Darith James, Arizona State University

Brief 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. 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).

Condition or disease Intervention/treatment Phase
Age-related Cognitive Decline Other: PNF Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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)
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Experimental: Intervention Arm
8 week 14 hour prolonged nightly fasting intervention.
Other: PNF
PNF Participants will engage in 8 weeks of 14 hours per night fasting




Primary Outcome Measures :
  1. Memory and Attention Phone Screener (MAPS) [ Time Frame: 8 weeks ]
    Cognitive Function and Performance Test.


Secondary Outcome Measures :
  1. Rapid Eating Assessment for Participants Scale (REAPS) [ Time Frame: 8 weeks ]
    Scale to asses eating behaviors. The scale has a minimum of 13 and a maximum of 39. Higher scores indicate higher diet quality.

  2. Insomnia Severity Index (ISI) [ Time Frame: 8 weeks ]
    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.

  3. Mindful Eating Scale (MES) [ Time Frame: 8 weeks ]
    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.

  4. Creature of Habit Scale (COHS) [ Time Frame: 8 weeks ]
    Scale to asses routine habits. Each item has a minimum of zero and a maximum of 4 where 4 means a more habitual nature.

  5. Salivary Cortisol [ Time Frame: 8 weeks ]
    Measure of cortisol via participant saliva samples.

  6. Body Mass Index (BMI) [ Time Frame: 8 weeks ]
    Self-reported body measurements .



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 65 or older
  • Self-identified age-related cognitive decline (ARCD)
  • Has a text capable phone and access to wifi

Exclusion Criteria:

  • Diagnosed with an eating disorder in the past 20 years
  • Works a night shift
  • Cannot participate in a 14 hour fast
  • Has diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04938778


Contacts
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Contact: Dara James, PhD 207-479-1440 dara.james@asu.edu

Locations
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United States, Arizona
Arizona State University Recruiting
Phoenix, Arizona, United States, 85004
Contact: Dara James, PhD    207-479-1440    dara.james@asu.edu   
Sub-Investigator: Linda K Larkey, PhD         
Sub-Investigator: David W Coon, PhD         
Sub-Investigator: Dorothy Sears, PhD         
Sub-Investigator: Molly Maxfeild, PhD         
Sub-Investigator: Edward Ofori, PhD         
Sponsors and Collaborators
Arizona State University
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Responsible Party: Darith James, Postdoctoral Researcher, Arizona State University
ClinicalTrials.gov Identifier: NCT04938778    
Other Study ID Numbers: 00012888
First Posted: June 24, 2021    Key Record Dates
Last Update Posted: June 29, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders