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RECRUITING
NCT06855784
NA

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

Sponsor: University Hospital, Geneva

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

45 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

84

Start Date

2025-04-30

Completion Date

2027-03-01

Last Updated

2026-01-27

Healthy Volunteers

No

Interventions

BEHAVIORAL

Time-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.

BEHAVIORAL

Active 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