MenopauseTREMHONCT06855784
Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO)
A study testing Time-Restricted Eating 16h/8h in people with Menopause and Obesity and Overweight, run by University Hospital, Geneva at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Menopause, Obesity and Overweight
- What is being tested?
- Time-Restricted Eating 16h/8h
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSwitzerland
- Study dates
- 30 Apr 2025to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Céline Joris, BSc contact
Switzerland1 site, 1 recruiting
- Recruiting
Geneva University Hospitals
Geneva, Canton of Geneva, 1211
Tinh-Hai Collet, MD, +41-22-372 91 92, tinh-hai.collet@hug.ch
Isabelle Streuli, MD
About this study
Official title: Time-Restricted Eating to Improve Body Composition and Symptoms in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) - An Open-label Randomized Controlled Trial
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
- Being tested
- Time-Restricted Eating 16h/8h, Active Control
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-Restricted Eating 16h/8hBehavioural
Also called TRE 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 ControlBehavioural
Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities
| Study group | Role | What they receive |
|---|---|---|
| Time-Restricted Eating | Experimental | Not described Receives: Behavioral: Time-Restricted Eating 16h/8h |
| Active Control | Active comparator | Not described Receives: Behavioral: Active Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in body weight
Measured (in Kg) in light clothing using a calibrated medical-grade scale
Measured: From randomization visit to close-out visit (12 weeks)
Changes in body fat mass
Measured (in Kg) by dual-energy x-ray absorptiometry (DXA)
Measured: From randomization visit to close-out visit (12 weeks)
Secondary outcomes (22)
Changes in menopause / climacteric symptoms
Assessed by questionnaire
Measured: From randomization visit to close-out visit (12 weeks)
Changes in bone mineral density
Measured (in g/cm3) by dual-energy x-ray absorptiometry (DXA)
Measured: From randomization visit to close-out visit (12 weeks)
Changes in bone turnover marker CTX
C-telopeptide cross-linked type 1 collagen (CTX) measured (in ng/L) by clinical chemistry
Measured: From randomization visit to close-out visit (12 weeks)
Changes in bone turnover marker P1NP
Procollagen type 1 N-terminal propeptide (P1NP) measured (in μg/L) by clinical chemistry
Measured: From randomization visit to close-out visit (12 weeks)
Changes in joint pain
Joint pain assessed by questionnaire (0 = absent to 7 = Extremely bothered)
Measured: From randomization visit to close-out visit (12 weeks)
Changes in body mass index (BMI)
Expressed in percent of baseline value (body mass index = weight in Kg divided by the height in meters squared, unit Kg/m2)
Measured: From randomization visit to close-out visit (12 weeks)
Changes in waist circumference
Measured (in cm) with a measuring tape, following the WHO 2008 Expert Report
Measured: From randomization visit to close-out visit (12 weeks)
Changes in hip circumference
Measured (in cm) with a measuring tape, following the WHO 2008 Expert Report
Measured: From randomization visit to close-out visit (12 weeks)
Changes in systolic and diastolic blood pressure
Measured (in mmHg) with an arm cuff in the sitting position
Measured: From randomization visit to close-out visit (12 weeks)
Changes in fasting plasma glucose
Measured (in mmol/L) by clinical chemistry
Measured: From randomization visit to close-out visit (12 weeks)
Changes in lipid profile
Total cholesterol, LDL cholesterol, triglycerides and HDL cholesterol concentrations measured (in mmol/L) by clinical chemistry
Measured: From randomization visit to close-out visit (12 weeks)
Changes in lean body mass
Measured (in Kg) by dual-energy x-ray absorptiometry (DXA)
Measured: From randomization visit to close-out visit (12 weeks)
Changes in body composition
Fat mass and fat-free mass (in Kg) measured by bioelectrical impedance analysis (BIA)
Measured: From randomization visit to close-out visit (12 weeks)
Changes in muscle function
Measured (in Kg) by handgrip strength
Measured: From randomization visit to close-out visit (12 weeks)
Changes in glucose excursion
Measured by continuous glucose monitoring
Measured: From randomization visit to close-out visit (12 weeks)
Changes in metabolomic profile
Measured by high-throughput mass spectrometry metabolomics
Measured: From randomization visit to close-out visit (12 weeks)
Changes in physical activity
Measured by actigraphy (in activity counts, CamNTech proprietary algorithm) and by the International Physical Activity Questionnaire (IPAQ, aggregated in MET-minutes/week)
Measured: From randomization visit to close-out visit (12 weeks)
Changes in sleep/wake cycles
Measured by actigraphy assessed as time of sleep onset and wake-up in 24-hour cycle
Measured: From randomization visit to close-out visit (12 weeks)
Changes in sleep duration
Measured by actigraphy
Measured: From randomization visit to close-out visit (12 weeks)
Changes in body temperature
Measured by body temperature wearable device
Measured: From randomization visit to close-out visit (12 weeks)
Changes in sleep quality
Assessed by the Pittsburgh Sleep Quality Index [PSQI, minimum score = 0 (better); maximum score = 21 (worse)]
Measured: From randomization visit to close-out visit (12 weeks)
Changes in eating duration
Duration from the first to last caloric intake over 24-hour cycle
Measured: From randomization visit to close-out visit (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start30 Apr 2025
- Primary completion1 Mar 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MenopauseStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tinh-Hai Collet, MD, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06855784
- Sponsor's protocol ID
- 2024-01257
- Acronym
- TREMHO
- Status last verified
- Jan 2026
- First submitted
- 15 Feb 2025
- Last updated
- 27 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-Restricted Eating to Improve Body Composition and Symptoms in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) - An Open-label Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06855784
- Acronym / sponsor ID
- TREMHO / 2024-01257
- Conditions
- Menopause, Obesity and Overweight
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 4 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time-Restricted Eating | Experimental | Behavioral: Time-Restricted Eating 16h/8h |
| Active Control | Active comparator | Behavioral: Active Control |
Who may qualify
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-Restricted Eating 16h/8hAlso: TRE 16h/8hParticipants 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. | Behavioural | Time-Restricted Eating |
| Active ControlParticipants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities | Behavioural | Active Control |
Primary outcome
Changes in body weight
Time frame: 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
Time frame: From randomization visit to close-out visit (12 weeks)
Measured (in Kg) by dual-energy x-ray absorptiometry (DXA)
22 secondary outcomes
Changes in menopause / climacteric symptoms
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in bone mineral density
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in bone turnover marker CTX
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in bone turnover marker P1NP
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in joint pain
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in body mass index (BMI)
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in waist circumference
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in hip circumference
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in systolic and diastolic blood pressure
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in fasting plasma glucose
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in lipid profile
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in lean body mass
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in body composition
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in muscle function
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in glucose excursion
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in metabolomic profile
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in physical activity
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in sleep/wake cycles
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in sleep duration
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in body temperature
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in sleep quality
Time frame: From randomization visit to close-out visit (12 weeks)
Changes in eating duration
Time frame: From randomization visit to close-out visit (12 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Céline Joris, BSc contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-Restricted Eating 16h/8h in people with Menopause and Obesity and Overweight, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tinh-Hai Collet, MD (+41-22-372 91 92, tinh-hai.collet@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in body weight (time frame: From randomization visit to close-out visit (12 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2026.