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Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

Primary Purpose

Metabolic Syndrome, Postmenopausal Symptoms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Time-Restricted Feeding (TRF)
Sponsored by
Julie Pendergast
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome focused on measuring postmenopause, weight, metabolic risk, glucose, body composition, lipid, sleep, prediabetes, fasting, circadian, inflammation

Eligibility Criteria

45 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • on hormone therapy
  • smokers
  • diabetes
  • heart disease
  • any acute or chronic inflammatory condition
  • alcohol consumption of >7 drinks per week
  • significant circadian disruption
  • living with children under 2 years old
  • shift work or irregular lifestyle
  • diagnosed sleep apnea or sleep disorder
  • extreme early or late chronotypes
  • significant psychiatric disorders or ADHD
  • history of dysregulated eating behaviors

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control

Time-Restricted Feeding (TRF) Group

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Insulin Sensitivity
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Change in Body Mass Index
Body mass index will be calculated from height and weight.
Change in Triglycerides
Triglycerides will be measured from fasting blood

Secondary Outcome Measures

Change in Hemoglobin A1c
HbA1c is a measure of the proportion of glycated hemoglobin in blood.
Change in C-Reactive Protein
CRP will be measured from blood samples.
Change in Mid-sleep
Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.
Change in Sleep Fragmentation Index
Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data.

Full Information

First Posted
May 12, 2021
Last Updated
November 15, 2022
Sponsor
Julie Pendergast
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT04893226
Brief Title
Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
Official Title
Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 19, 2021 (Actual)
Primary Completion Date
February 27, 2026 (Anticipated)
Study Completion Date
February 27, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Julie Pendergast
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Postmenopausal Symptoms
Keywords
postmenopause, weight, metabolic risk, glucose, body composition, lipid, sleep, prediabetes, fasting, circadian, inflammation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
164 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm 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.
Arm Title
Time-Restricted Feeding (TRF) Group
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Time-Restricted Feeding (TRF)
Intervention Description
Subjects will be educated about the health benefits of time-restricted feeding (TRF). Each subject in the TRF group will self-select a 10 hour (10h +/- 1hr) window aligned with their active phase during which they will consume all daily calories. Subjects will text the time of their first and last daily meals for the duration of the study.
Primary Outcome Measure Information:
Title
Change in Insulin Sensitivity
Description
Matsuda index will be assessed by the oral glucose tolerance test (OGTT).
Time Frame
18 weeks (baseline and post-intervention)
Title
Change in Body Mass Index
Description
Body mass index will be calculated from height and weight.
Time Frame
18 weeks (baseline and post-intervention)
Title
Change in Triglycerides
Description
Triglycerides will be measured from fasting blood
Time Frame
18 weeks (baseline and post-intervention)
Secondary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Description
HbA1c is a measure of the proportion of glycated hemoglobin in blood.
Time Frame
18 weeks (baseline and post-intervention)
Title
Change in C-Reactive Protein
Description
CRP will be measured from blood samples.
Time Frame
18 weeks (baseline and post-intervention)
Title
Change in Mid-sleep
Description
Mid-sleep is a single outcome calculated using both actigraphy and sleep log information.
Time Frame
18 weeks (baseline and post-intervention)
Title
Change in Sleep Fragmentation Index
Description
Sleep fragmentation index, a measure of sleep quality, will be assessed from actigraphy data.
Time Frame
18 weeks (baseline and post-intervention)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: postmenopausal women age 45-65 years sedentary prediabetic or have at least 2 features of metabolic syndrome Exclusion Criteria: on hormone therapy smokers diabetes heart disease any acute or chronic inflammatory condition alcohol consumption of >7 drinks per week significant circadian disruption living with children under 2 years old shift work or irregular lifestyle diagnosed sleep apnea or sleep disorder extreme early or late chronotypes significant psychiatric disorders or ADHD history of dysregulated eating behaviors
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matt Thomas, PhD
Phone
(859) 218-6770
Email
jmthomg@uky.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julie S Pendergast, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matt Thomas, PhD
Phone
859-218-6770
Email
jmthomg@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Time-Restricted Feeding Intervention in Metabolically-Unhealthy Postmenopausal Women

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