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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 below

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I am a healthy woman aged between 40 and 58.

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I have high cholesterol or other lipid disorders increasing my heart disease risk.

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My kidney and liver are functioning normally.

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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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and assessed daily over 1 week at baseline (week 0) and post-intervention (week 8) for reporting.

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 more

Other 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor

1,616 Previous Clinical Trials

11,470,850 Total Patients Enrolled

8 Trials studying Menopause

122,726 Patients Enrolled for Menopause

Leilah K Grant, PhDPrincipal InvestigatorBrigham and Women's Hospital

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being recruited for participation in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this specific clinical trial is actively seeking individuals to participate. The initial posting of the study occurred on December 21st, 2022 and it was last updated on December 18th, 2023. To complete the trial successfully, a total of 100 participants will be enrolled from one location."

Answered by AI

Is the enrollment for this clinical trial currently open?

"Indeed, according to the information available on clinicaltrials.gov, this research endeavor is actively seeking eligible participants. The trial was initially posted on December 21st, 2022 and underwent its most recent update on December 18th, 2023. A total of 100 patients will be enrolled in this study from a single location."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The main focus of this trial is to evaluate the impact on visceral adiposity, with measurements taken at both baseline (week 0) and post-intervention (week 8). Secondary outcomes include changes in systolic blood pressure, body weight, and sleep duration. Systolic blood pressure change will be assessed by comparing pre- and post-intervention values in mmHg. Body weight change will be determined by comparing pre- and post-intervention weights in kilograms. Sleep duration change will be evaluated based on self-reported average sleep duration over a one-week period."

Answered by AI

Does this research involve enrolling participants who are above the age of 65?

"To be eligible for participation in this clinical trial, individuals must fall within the age range of 40 to 58. It is noteworthy that there are a total of 176 trials available specifically for patients under the age of 18 and an additional 665 trials tailored for individuals over the age of 65."

Answered by AI

Do I meet the necessary criteria to participate in this clinical investigation?

"Candidates who are between the ages of 40 and 58, and have dyslipidemia, may be eligible for this clinical trial. The study aims to recruit a total of 100 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Time-restricted Eating in Peri- and Postmenopausal Women

Leilah Kristine Grant 2022. "Time-restricted Eating in Peri- and Postmenopausal Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06188598.

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