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Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
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.
Conditions:
🦠 Metabolic Syndrome 🦠 Postmenopausal Symptoms
🗓️ Study Start (Actual) 19 October 2021
🗓️ Primary Completion (Estimated) 27 February 2026
✅ Study Completion (Estimated) 27 February 2026
👥 Enrollment (Estimated) 164
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Lexington, Kentucky, United States

📋 Eligibility Criteria

Description

    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 sleep disorder
    • * extreme early or late chronotypes
    • * significant psychiatric disorders or ADHD
    • * diagnosed dysregulated eating behaviors
Ages Eligible for Study: 45 Years to 65 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 12 May 2021
  • First Submitted that Met QC Criteria 17 May 2021
  • First Posted 19 May 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 November 2023
  • Last Update Posted 24 November 2023
  • Last Verified November 2023
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