Think FAST Research Study

• Sponsor: Arizona State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04938778
• Collaborator: (none)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 17.9
• Patients Per Site Per Month: 1.1

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Age-related Cognitive Decline	Other: PNF	N/A

Study Design

• Study Type: Interventional
• Actual 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: Feb 1, 2021
• Actual Primary Completion Date: Jul 30, 2022
• Actual Study Completion Date: Jul 30, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Memory and Attention Phone Screener (MAPS) [8 weeks]

   Cognitive Function and Performance Test.

Secondary Outcome Measures

1. Rapid Eating Assessment for Participants Scale (REAPS) [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) [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) [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) [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 [8 weeks]

   Measure of cortisol via participant saliva samples.

6. Body Mass Index (BMI) [8 weeks]

   Self-reported body measurements .

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona State University	Phoenix	Arizona	United States	85004

Sponsors and Collaborators

• Arizona State University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Darith James, Postdoctoral Researcher, Arizona State University
• ClinicalTrials.gov Identifier: NCT04938778
• Other Study ID Numbers: 00012888
• First Posted: Jun 24, 2021
• Last Update Posted: Aug 4, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cognitive Dysfunction

Study Results

No Results Posted as of Aug 4, 2022