Think FAST Research Study

Age-related Cognitive Decline Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04938778
• Other study ID #: 00012888
• Status: Completed
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: July 30, 2022

Study information

• Verified date: August 2022
• Source: Arizona State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: July 30, 2022
• Est. primary completion date: July 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Cognitive Decline
• Cognitive Dysfunction

Intervention

Other:
• PNF
PNF Participants will engage in 8 weeks of 14 hours per night fasting

Locations

Country	Name	City	State
United States	Arizona State University	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Arizona State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Memory and Attention Phone Screener (MAPS)	Cognitive Function and Performance Test.	8 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Salivary Cortisol	Measure of cortisol via participant saliva samples.	8 weeks
Secondary	Body Mass Index (BMI)	Self-reported body measurements .	8 weeks