Think FAST Research Study

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).

Study Overview

• Status: Completed
• Conditions: Age-related Cognitive Decline
• Intervention / Treatment: Other: PNF

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85004
      • Arizona State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Memory and Attention Phone Screener (MAPS)	Cognitive Function and Performance Test.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	8 weeks
Salivary Cortisol	Measure of cortisol via participant saliva samples.	8 weeks
Body Mass Index (BMI)	Self-reported body measurements .	8 weeks

Collaborators and Investigators

• Sponsor: Arizona State University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 24, 2021

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 00012888

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No