Time-restricted eating for menopausal women and those on hormone therapy for breast cancer
Time-Restricted Eating to Improve Body Composition and Symptoms in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) - An Open-label Randomized Controlled Trial
This trial will test whether eating only during an 8-hour window each day (16:8 time-restricted eating) helps overweight menopausal women and women taking aromatase inhibitors manage weight and symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | 45 Years to 60 Years |
| Sex | Female |
| Sponsor | University Hospital, Geneva Academic / other |
| Locations | 1 site (Geneva, Canton of Geneva) |
| Trial ID | NCT06855784 on ClinicalTrials.gov |
What this trial studies
Participants are women aged 40–65 with BMI 25–40 kg/m2 who are either in physiological menopause or experiencing menopause-related symptoms while taking aromatase inhibitors for hormone-sensitive non-metastatic breast cancer. After a run-in period to confirm baseline eating patterns, participants are randomized to a 12-week 16-hour daily fast/8-hour eating window or to continue their usual eating pattern, with total participation lasting 14 weeks and an optional 12-month follow-up. The intervention uses smartphone food photos and monitoring to support adherence and outcome measurement. Primary outcomes focus on weight and menopause-related symptoms, with safety and feasibility also tracked.
Who should consider this trial
Good fit: Ideal candidates are women 40–65 years old with BMI 25–40 kg/m2 who are in physiological menopause or have menopause symptoms while on aromatase inhibitors, have stable weight, an eating window ≥12 hours at baseline, and can use a smartphone to take food photos.
Not a fit: Patients already on hypocaloric or intermittent fasting programs, with prior bariatric surgery, active eating disorders, major uncontrolled psychiatric illness, or who cannot comply with the fasting schedule are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the approach could slow weight gain, reduce menopausal symptoms, and improve quality of life using a simple, non-pharmacologic eating schedule.
How similar studies have performed: Some smaller trials of time-restricted eating in overweight adults have shown modest weight and metabolic benefits, but evidence specifically in menopausal women and those on aromatase inhibitors is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with confirmed physiological menopause without current anti-cancer treatment (group A), or women with menopausal symptoms in the context of aromatase inhibitors used as adjuvant therapy for hormone-sensitive non-metastatic breast cancers regardless of physiological menopause before the cancer diagnosis (group B) * Age 40-65 years * Body mass index 25-40 kg/m2 * Stable weight (± 2 kg) over the previous month * Eating window ≥ 12 hours (self-reported and measured during the run-in phase) * Able to give informed consent and follow the study procedures for the entire duration * Confident use of a smartphone and able to take regular pictures of food/drinks Exclusion Criteria: * On a hypocaloric restrictive diet, intermittent fasting or in a weight management program over the previous month * Previous bariatric surgery or planned during the study * Active eating disorder(s) or major mental illness at inclusion * Psychoactive treatment with recent or planned changes of drug compound or dosage * Treatments affecting body weight (e.g. glucocorticoids, GLP-1 receptor analogues) * Diabetes with hypoglycemic drug(s) will be excluded, however those with prediabetes (as defined by the American Diabetes Association) or diabetes with no risk of hypoglycemia (i.e. treated with non-hypoglycemic drugs or without medication) will be included * Active metabolic bone diseases (e.g. Paget disease, osteomalacia), however women with osteoporosis will be included * Shift work comprising night shifts (working between 11pm and 6am) over the previous 2 weeks or planned during the study * Travel/trip to a different time zone (≥ 2-hour time difference) over the previous 2 weeks or planned during the study * Enrolled in another interventional clinical trial (medication, surgery, medical device) over the previous 2 weeks or planned during the study
Where this trial is running
Geneva, Canton of Geneva
- Geneva University Hospitals — Geneva, Canton of Geneva, Switzerland (Recruiting)
Study contacts
- Study coordinator: Tinh-Hai Collet, MD
- Email: tinh-hai.collet@hug.ch
- Phone: +41-22-372 91 92
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.