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Think FAST Research Study

Primary Purpose

Age-related Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PNF
Sponsored by
Arizona State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Age-related Cognitive Decline

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona State University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Arm

Arm Description

8 week 14 hour prolonged nightly fasting intervention.

Outcomes

Primary Outcome Measures

Memory and Attention Phone Screener (MAPS)
Cognitive Function and Performance Test.

Secondary Outcome Measures

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.
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.
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.
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.
Salivary Cortisol
Measure of cortisol via participant saliva samples.
Body Mass Index (BMI)
Self-reported body measurements .

Full Information

First Posted
March 10, 2021
Last Updated
August 3, 2022
Sponsor
Arizona State University
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1. Study Identification

Unique Protocol Identification Number
NCT04938778
Brief Title
Think FAST Research 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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Arizona State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Cognitive Decline

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention Arm
Arm Type
Experimental
Arm Description
8 week 14 hour prolonged nightly fasting intervention.
Intervention Type
Other
Intervention Name(s)
PNF
Intervention Description
PNF Participants will engage in 8 weeks of 14 hours per night fasting
Primary Outcome Measure Information:
Title
Memory and Attention Phone Screener (MAPS)
Description
Cognitive Function and Performance Test.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Rapid Eating Assessment for Participants Scale (REAPS)
Description
Scale to asses eating behaviors. The scale has a minimum of 13 and a maximum of 39. Higher scores indicate higher diet quality.
Time Frame
8 weeks
Title
Insomnia Severity Index (ISI)
Description
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.
Time Frame
8 weeks
Title
Mindful Eating Scale (MES)
Description
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.
Time Frame
8 weeks
Title
Creature of Habit Scale (COHS)
Description
Scale to asses routine habits. Each item has a minimum of zero and a maximum of 4 where 4 means a more habitual nature.
Time Frame
8 weeks
Title
Salivary Cortisol
Description
Measure of cortisol via participant saliva samples.
Time Frame
8 weeks
Title
Body Mass Index (BMI)
Description
Self-reported body measurements .
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Arizona State University
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States

12. IPD Sharing Statement

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Think FAST Research Study

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