Your session is about to expire
← Back to Search
Behavioural Intervention
Time-restricted eating (TRE) for Menopause
N/A
Recruiting
Led By Leilah K Grant, PhD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Healthy women aged 40-58 years
Dyslipidemic, defined as the presence of one or more lipid-based CVD risk-enhancing factors per ACC/AHA guidelines
Timeline
Screening 3 weeks
Treatment Varies
Follow Up assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Awards & highlights
Study Summary
This trial aims to see how restricting eating to only an 8-hour window each day affects the levels of fats in the blood and the composition of the body in women who are going through or have recently
Who is the study for?
This trial is for peri- and postmenopausal women who have high levels of lipids in their blood (dyslipidemia) and haven't been treated for it. It's not clear from the provided information what specific inclusion or exclusion criteria are set, so additional details would be needed to complete this section.Check my eligibility
What is being tested?
The study is testing whether eating within an 8-hour window can improve lipid levels and body composition in women going through menopause or who have recently gone through it.See study design
What are the potential side effects?
Since the intervention involves dietary changes rather than medication, side effects may include hunger outside of eating hours, potential changes in energy levels, or gastrointestinal discomfort as the body adjusts.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a healthy woman aged between 40 and 58.
Select...
I have high cholesterol or other lipid disorders increasing my heart disease risk.
Select...
My kidney and liver are functioning normally.
Select...
I am perimenopausal and my pregnancy test is negative.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in fasting triglyceride levels
Change in visceral adiposity
Secondary outcome measures
Change in body weight
Change in depressive symptoms
Change in high-density lipoprotein cholesterol (HDL-C)
+6 moreOther outcome measures
Time-course of triglyceride levels across 8 weeks
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Time-restricted eating (TRE)Experimental Treatment1 Intervention
Participants in the TRE group are instructed to restrict eating to an 8-hr window but were not asked to change the type or amount of food typically consumed. The 8-hour window (e.g., 10am - 6pm) has to be the same each day starting at least 2 hours after wake and ending at least 2 hours before bed.
Group II: Unrestricted eatingActive Control1 Intervention
Participants are instructed to continue their diet as normal without changing the type, amount or timing of food typically consumed.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Time-restricted eating
2022
N/A
~520
Find a Location
Who is running the clinical trial?
Brigham and Women's HospitalLead Sponsor
1,622 Previous Clinical Trials
11,468,657 Total Patients Enrolled
8 Trials studying Menopause
122,726 Patients Enrolled for Menopause
Leilah K Grant, PhDPrincipal InvestigatorBrigham and Women's Hospital
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger