Think FAST Research Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04938778|
Recruitment Status : Recruiting
First Posted : June 24, 2021
Last Update Posted : June 29, 2021
|Condition or disease||Intervention/treatment||Phase|
|Age-related Cognitive Decline||Other: PNF||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
Experimental: Intervention Arm
8 week 14 hour prolonged nightly fasting intervention.
PNF Participants will engage in 8 weeks of 14 hours per night fasting
- Memory and Attention Phone Screener (MAPS) [ Time Frame: 8 weeks ]Cognitive Function and Performance Test.
- 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.
- 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.
- 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.
- 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.
- Salivary Cortisol [ Time Frame: 8 weeks ]Measure of cortisol via participant saliva samples.
- Body Mass Index (BMI) [ Time Frame: 8 weeks ]Self-reported body measurements .
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
|Contact: Dara James, PhDfirstname.lastname@example.org|
|United States, Arizona|
|Arizona State University||Recruiting|
|Phoenix, Arizona, United States, 85004|
|Contact: Dara James, PhD 207-479-1440 email@example.com|
|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|