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OpenTrials
Completed

NCT Number: NCT04938778

Think FAST Research Study

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).

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Key information

Conditions

Age-related Cognitive Decline

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Phoenix, Arizona, 85004, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PNF

Other

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

Primary outcomes

  1. Memory and Attention Phone Screener (MAPS)

    Time frame: 8 weeks

    Cognitive Function and Performance Test.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Salivary Cortisol

    Time frame: 8 weeks

    Measure of cortisol via participant saliva samples.

  6. Body Mass Index (BMI)

    Time frame: 8 weeks

    Self-reported body measurements .

Sponsors and collaborators

Lead sponsor

Arizona State University

Other

Registry information

Official study 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)

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jun 24, 2021
Registry last updated
Aug 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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