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Behavioural Intervention

Time-restricted Eating 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

Must not have

Diagnosis or strong clinical suspicion of eating disorders, including anorexia nervosa, bulimia nervosa, binge eating disorder

Current major depressive episode

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assessed daily over 1 week at baseline (week 0) and post-intervention (week 8)

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have or am suspected to have an eating disorder like anorexia, bulimia, or binge eating.

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I am currently experiencing a major depressive episode.

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I am currently taking medication or supplements for weight loss.

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I have had weight loss surgery in the past.

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I was diagnosed with cancer in the last 2 years.

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I have not had major surgery in the last 3 months.

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I am taking medication to manage my cholesterol levels.

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I am currently using hormone therapy.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in fasting triglyceride levels

Change in visceral adiposity

Secondary study objectives

Change in body weight

Change in depressive symptoms

Change in high-density lipoprotein cholesterol (HDL-C)

+6 more

Other study objectives

Time-course of triglyceride levels across 8 weeks

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~850

0 / 12Eligibility criteria met