NCT04938778

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 10, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 24, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 4, 2022

Status Verified

August 1, 2022

Enrollment Period

1.5 years

First QC Date

March 10, 2021

Last Update Submit

August 3, 2022

Conditions

Age-related Cognitive Decline

Outcome Measures

Primary Outcomes (1)

  • Memory and Attention Phone Screener (MAPS)

    Cognitive Function and Performance Test.

    8 weeks

Secondary Outcomes (6)

  • Rapid Eating Assessment for Participants Scale (REAPS)

    8 weeks

  • Insomnia Severity Index (ISI)

    8 weeks

  • Mindful Eating Scale (MES)

    8 weeks

  • Creature of Habit Scale (COHS)

    8 weeks

  • Salivary Cortisol

    8 weeks

  • +1 more secondary outcomes

Study Arms (1)

Intervention Arm

EXPERIMENTAL

8 week 14 hour prolonged nightly fasting intervention.

Other: PNF

Interventions

PNFOTHER

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

Intervention Arm

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • or older
  • Self-identified age-related cognitive decline (ARCD)
  • Has a text capable phone and access to wifi

You may not qualify if:

  • Diagnosed with an eating disorder in the past 20 years
  • Works a night shift
  • Cannot participate in a 14 hour fast
  • Has diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Arizona State University

Phoenix, Arizona, 85004, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postdoctoral Researcher

Study Record Dates

First Submitted

March 10, 2021

First Posted

June 24, 2021

Study Start

February 1, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

August 4, 2022

Record last verified: 2022-08

Locations

US(1)