RecruitingNot ApplicableNCT06855784

Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO)

Time-Restricted Eating to Improve Body Composition and Symptoms in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) - An Open-label Randomized Controlled Trial


Sponsor

University Hospital, Geneva

Enrollment

84 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study is aimed at women currently going through menopause, either as part of the natural process (physiological menopause), or following hormonal treatment for breast cancer. There are several ways of slowing the weight gain frequently encountered in this situation, reducing the intensity of menopause-related symptoms and improving quality of life in this context. In this trial, the investigators examine the efficacy and possible adverse effects of intermittent fasting compared with a control intervention. Participation lasts 14 weeks, with an optional 12-month follow-up. Study participants are randomly assigned to either the intervention group or the control group. In the intervention group, study participants fast for 16 hours per day and eat over a period of 8 hours (intermittent fasting often called time-restricted eating \[TRE\] 16h/8h). In the control group, the usual eating pattern is continued for 12 weeks. The main objective of the study is to evaluate the efficacy of TRE in terms of weight and fat loss, improvement in metabolic profile, menopausal symptoms and bone health. In addition, the study team closely monitors any adverse effects.


Eligibility

Sex: FEMALEMin Age: 45 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether time-restricted eating (limiting all meals to a shorter window of the day) can help reduce menopausal symptoms and improve metabolic health in women going through menopause — either naturally or as a side effect of breast cancer treatment. **You may be eligible if...** - You are a woman aged 40–65 - You are in natural menopause (without active cancer treatment) OR experiencing menopausal symptoms due to aromatase inhibitor therapy for non-metastatic hormone-sensitive breast cancer - Your BMI is between 25 and 40 - Your weight has been stable (within 2 kg) over the past month - You currently eat across a window of 12 hours or more each day - You are comfortable using a smartphone and can photograph your meals **You may NOT be eligible if...** - You are currently on a calorie-restricted diet, intermittent fasting, or weight loss program - You have had or are planning bariatric surgery - You have an active eating disorder or serious mental illness - You work night shifts or travel across time zones regularly - You take medications that affect body weight (like steroids or GLP-1 drugs) - You have diabetes requiring medication that lowers blood sugar Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALTime-Restricted Eating 16h/8h

Participants will be advised to eat only during a self-selected window of 8 hours over the 24-hour cycle, with a 1-hour allowance according to their daily routine.

BEHAVIORALActive Control

Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities


Locations(1)

Geneva University Hospitals

Geneva, Canton of Geneva, Switzerland

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NCT06855784


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