NCT06855784

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: University Hospital, Geneva · Academic / Other
• Sex: Female
• Age: 45 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Menopause
• Obesity and Overweight

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-04-30
• Primary completion: 2027-03-01
• Completion: 2027-03-01
• First posted: 2025-03-04
• Last updated: 2026-01-27

Locations

1 site across 1 country: Switzerland