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

Not Applicable

Not yet recruiting

• Conditions: Menopause; Obesity and Overweight

• Registration Number: NCT06855784
• Lead Sponsor: University Hospital, Geneva

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study First Submitted: 2025-02-15
• Study First Submitted QC: 2025-02-27
• Last Update Submitted: 2025-02-27
• Study Start: 2025-03-01
• Study First Posted: 2025-03-04
• Last Update Posted: 2025-03-04
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 84

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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)

Secondary Outcome Measures

Name	Time	Method
Changes in body mass index (BMI)	From randomization visit to close-out visit (12 weeks)	Expressed in percent of baseline value (body mass index = weight in Kg divided by the height in meters squared, unit Kg/m2)
Changes in waist circumference	From randomization visit to close-out visit (12 weeks)	Measured (in cm) with a measuring tape, following the WHO 2008 Expert Report
Changes in fasting plasma glucose	From randomization visit to close-out visit (12 weeks)	Measured (in mmol/L) by clinical chemistry
Changes in lipid profile	From randomization visit to close-out visit (12 weeks)	Total cholesterol, LDL cholesterol, triglycerides and HDL cholesterol concentrations measured (in mmol/L) by clinical chemistry
Changes in lean body mass	From randomization visit to close-out visit (12 weeks)	Measured (in Kg) by dual-energy x-ray absorptiometry (DXA)
Changes in metabolomic profile	From randomization visit to close-out visit (12 weeks)	Measured by high-throughput mass spectrometry metabolomics
Changes in physical activity	From randomization visit to close-out visit (12 weeks)	Measured by actigraphy (in activity counts, CamNTech proprietary algorithm) and by the International Physical Activity Questionnaire (IPAQ, aggregated in MET-minutes/week)
Changes in sleep/wake cycles	From randomization visit to close-out visit (12 weeks)	Measured by actigraphy assessed as time of sleep onset and wake-up in 24-hour cycle
Changes in sleep duration	From randomization visit to close-out visit (12 weeks)	Measured by actigraphy
Changes in body temperature	From randomization visit to close-out visit (12 weeks)	Measured by body temperature wearable device
Changes in eating duration	From randomization visit to close-out visit (12 weeks)	Duration from the first to last caloric intake over 24-hour cycle
Changes in menopause / climacteric symptoms	From randomization visit to close-out visit (12 weeks)	Assessed by questionnaire
Changes in bone mineral density	From randomization visit to close-out visit (12 weeks)	Measured (in g/cm3) by dual-energy x-ray absorptiometry (DXA)
Changes in bone turnover marker CTX	From randomization visit to close-out visit (12 weeks)	C-telopeptide cross-linked type 1 collagen (CTX) measured (in ng/L) by clinical chemistry
Changes in bone turnover marker P1NP	From randomization visit to close-out visit (12 weeks)	Procollagen type 1 N-terminal propeptide (P1NP) measured (in μg/L) by clinical chemistry
Changes in joint pain	From randomization visit to close-out visit (12 weeks)	Joint pain assessed by questionnaire (0 = absent to 7 = Extremely bothered)
Changes in hip circumference	From randomization visit to close-out visit (12 weeks)	Measured (in cm) with a measuring tape, following the WHO 2008 Expert Report
Changes in systolic and diastolic blood pressure	From randomization visit to close-out visit (12 weeks)	Measured (in mmHg) with an arm cuff in the sitting position
Changes in body composition	From randomization visit to close-out visit (12 weeks)	Fat mass and fat-free mass (in Kg) measured by bioelectrical impedance analysis (BIA)
Changes in muscle function	From randomization visit to close-out visit (12 weeks)	Measured (in Kg) by handgrip strength
Changes in glucose excursion	From randomization visit to close-out visit (12 weeks)	Measured by continuous glucose monitoring
Changes in sleep quality	From randomization visit to close-out visit (12 weeks)	Assessed by the Pittsburgh Sleep Quality Index \[PSQI, minimum score = 0 (better); maximum score = 21 (worse)\]

Trial Locations

Locations (1)

Geneva University Hospitals; 🇨🇭 Geneva, Switzerland