Actively Recruiting
Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO)
Led by University Hospital, Geneva · Updated on 2026-01-27
84
Participants Needed
1
Research Sites
95 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with confirmed physiological menopause without current anti-cancer treatment, or women with menopausal symptoms during aromatase inhibitor therapy for hormone-sensitive non-metastatic breast cancer
- Age between 40 and 65 years
- Body mass index between 25 and 40 kg/m2
- Stable weight within ±2 kg over the past month
- Eating window of 12 hours or more (self-reported and measured during run-in phase)
- Able to give informed consent and follow study procedures throughout the entire trial
- Comfortable using a smartphone and able to regularly photograph food and drinks
You will not qualify if you...
- Currently on a hypocaloric restrictive diet, intermittent fasting, or weight management program within the past month
- Previous or planned bariatric surgery during the study
- Active eating disorders or major mental illness at enrollment
- Recent or planned changes in psychoactive medications
- Use of treatments affecting body weight such as glucocorticoids or GLP-1 receptor analogues
- Diabetes treated with hypoglycemic drugs (prediabetes or diabetes without hypoglycemia risk allowed)
- Active metabolic bone diseases like Paget disease or osteomalacia (osteoporosis allowed)
- Night shift work between 11pm and 6am within the past 2 weeks or planned during the study
- Travel involving a time zone change of 2 hours or more within the past 2 weeks or planned during the study
- Participation in another interventional clinical trial within the past 2 weeks or planned during the study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland, 1211
Actively Recruiting
Research Team
T
Tinh-Hai Collet, MD
CONTACT
C
Céline Joris, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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