Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Julie Pendergast

Status: Enrolling

Conditions: Postmenopausal Symptoms; Metabolic Syndrome

Treatments: Behavioral: Time-Restricted Feeding (TRF)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04893226

BIO-21-TRF

1R01DK124774-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding on metabolic risk in postmenopausal women, who may be particularly vulnerable to disruption of circadian eating rhythms and the associated metabolic dysfunction. It is hypothesized that time-restricted feeding will improve insulin sensitivity, glucose tolerance, body weight, and other metabolic parameters in metabolically-unhealthy postmenopausal women.

Full description

This is a randomized, parallel two-arm clinical trial design to study the efficacy of time-restricted feeding (TRF) on metabolic risk in postmenopausal women. Data will be collected for 18 weeks. Baseline food timing, activity/sleep, and metabolic parameter (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers) data will be collected in the first two weeks (baseline). Subjects will then be randomized to the TRF intervention or no TRF for 16 weeks. Subjects in the TRF group will be educated about the health benefits of TRF. Then each subject in the TRF group will self-select a 10-h window and consume all daily calories during this time frame. Subjects in both the TRF and no TRF groups will text the time of their first and last daily meals for the duration of the study. At the end of the 16-week TRF intervention or no TRF, metabolic and anthropometric measurements will be collected.

Enrollment: 164 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• postmenopausal women
• age 45-65 years
• prediabetic or have at least 2 features of metabolic syndrome

Exclusion criteria

• on hormone therapy
• diabetes
• heart disease
• alcohol consumption of >2 drinks per day
• significant circadian disruption
• having care-taking responsibilities that significantly affect sleep
• shift work or irregular lifestyle
• uncontrolled sleep apnea or other uncontrolled sleep disorder
• extreme early or late chronotypes
• significant psychiatric disorders
• taking ADHD medications
• diagnosed dysregulated eating behaviors
• smoking >5 cigarettes/day or 30 pack-year history
• participating in formal weight loss program
• not weight stable

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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164 participants in 2 patient groups

Control

No Intervention group

Description:

Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). There will be no intervention.

Time-Restricted Feeding (TRF) Group

Experimental group

Description:

Participants in this group will have baseline and post-study data collected, including food timing, activity/sleep data, and metabolic parameters (OGTT, body composition, anthropometric measurements, lipid panel, inflammatory markers). Subjects in this group will be educated about the health benefits of time-restricted feeding (TRF). Then each subject in the TRF group will self-select a 10-h window during which she will consume all daily calories for 16 weeks.

Treatment:

Behavioral: Time-Restricted Feeding (TRF)