Clinical trial NCT06855784: Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO)
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Menopause
Obesity and Overweight
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2025-03-04
Enrollment: 84
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Women with physiological menopause confirmed (group A) or induced menopause in the context of adjuvant therapy for hormone-sensitive non-metastatic breast cancers (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
* 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)
* 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

Primary outcomes:
measure: Changes in body weight
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in body fat mass
timeFrame: From randomization visit to close-out visit (12 weeks)
Secondary outcomes:
measure: Changes in menopause / climacteric symptoms
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in bone mineral density
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in bone turnover marker CTX
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in bone turnover marker P1NP
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in joint pain
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in body mass index (BMI)
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in waist circumference
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in hip circumference
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in systolic and diastolic blood pressure
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in fasting plasma glucose
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in lipid profile
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in lean body mass
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in body composition
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in muscle function
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in glucose excursion
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in metabolomic profile
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in physical activity
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in sleep/wake cycles
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in sleep duration
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in body temperature
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in sleep quality
timeFrame: From randomization visit to close-out visit (12 weeks)
measure: Changes in eating duration
timeFrame: From randomization visit to close-out visit (12 weeks)
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: Geneva University Hospitals
Study officials:
References: