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

What this trial studies

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.

Conditions in scope

• Menopause
• Obesity and Overweight

Interventions

• Time-Restricted Eating 16h/8h (Behavioral) — 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.
• Active Control (Behavioral) — Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities

Who can join

Women only · Ages 45 Years to 60 Years

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

Eligibility wording paraphrased from the public record. View the full criteria on ClinicalTrials.gov before contacting a site.

Where it’s happening

Status & timeline

• Overall status: Recruiting
• Study type: Interventional
• Phase: N/A
• Start date: 2025-04-30
• Primary completion: 2027-03-01
• Last update posted: 2026-01-27
• First posted: 2025-03-04

Sponsor & contact

Lead sponsor: University Hospital, Geneva (Other)

For trial site contact information, use the official record at ClinicalTrials.gov. Contact details change frequently and the public record is the source of truth.

Outcome measures

Primary outcomes

• Changes in body weight (From randomization visit to close-out visit (12 weeks))
  Measured (in Kg) in light clothing using a calibrated medical-grade scale
• Changes in body fat mass (From randomization visit to close-out visit (12 weeks))
  Measured (in Kg) by dual-energy x-ray absorptiometry (DXA)

Related ClearedRx care

If you’re reading this trial because you have menopause symptoms now, you don’t have to wait for a trial to access evidence-based care. ClearedRx prescribes the same FDA-approved and compounded HRT products that have been studied in trials like this one for decades.