Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO)
NCT ID: NCT06855784
Last Updated: 2026-01-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
84 participants
INTERVENTIONAL
2025-04-30
2027-03-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Time-Restricted Eating
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.
Active Control
Active Control
Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities
Interventions
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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.
Active Control
Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
45 Years
60 Years
FEMALE
No
Sponsors
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University Hospital, Geneva
OTHER
Responsible Party
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Tinh-Hai Collet, MD
Assistant Professor
Locations
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Geneva University Hospitals
Geneva, Canton of Geneva, Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-01257
Identifier Type: -
Identifier Source: org_study_id
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