Fasting ENHANCE Pilot Study

Summary

Grounded in the principles of geroscience, the proposed Fasting ENHANCE study will test whether a time restricted eating (TRE) regimen can improve cognitive function and other aspects of successful aging in a safe and sustainable manner in at risk overweight older adults. Specifically, this study will evaluate whether TRE can improve cognitive and physical function, as well as self-reported sleep, mood, and quality of life, in overweight, older adults (age \> 65 years) who are at high risk of cognitive decline due to self-reported cognitive difficulties. Eligible participants will be assigned to either a TRE intervention, in which they will be instructed to fast for a target of 16 hours per day, or a successful aging (SA) comparison group for a 24-week period.

Conditions

• Overweight and Obesity
• Time Restricted Feeding
• Alzheimer Disease

Interventions

BEHAVIORAL

Time Restricted Eating intervention

In the TRE intervention, participants will be asked to fast for a target of 16 hours per day for a period of 24 weeks. The first few weeks will involve of a ramp up to a full 16-hour fasting period (Week 1 - fast for 12-14 hours per day, Week 2 - fast for 14-16 hours per day, Week 3 - 16 - fast for 16 hours per day). Participants will be allowed to consume calorie-free beverages, tea, black coffee, sugar-free gum, and they will be encouraged to drink plenty of water throughout the entire intervention period. Participants will be asked to record the time of first and final food/drink consumption each day. Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.

BEHAVIORAL

Successful Aging Comparison Group (LEARN)

In the Successful Aging Comparison Group (LEARN), participants will attend lectures on topic relevant to healthy aging at the same frequency as the group meetings in the TRE intervention. Both the TRE and Successful Aging comparison group will be group-mediated, with equal number of contact visits from study staff consisting of 10 group sessions over 24 weeks.

Sponsors & Collaborators

• Florida Department of Health, Ed and Ethel Moore Alzheimer's Disease Research Program

  collaborator UNKNOWN

• University of Florida

  lead OTHER

Principal Investigators

• Stephen Anton, Ph.D. · University of Florida

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-03-13

Primary Completion

2026-05-31

Completion

2026-06-30

Countries

• United States

Study Locations