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

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.

Study Overview

• Status: Recruiting
• Conditions: Menopause; Obesity and Overweight
• Intervention / Treatment: Behavioral: Time-Restricted Eating 16h/8h; Behavioral: Active Control

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tinh-Hai Collet, MD; Phone Number: +41-22-372 91 92; Email: tinh-hai.collet@hug.ch
• Study Contact Backup: Name: Céline Joris, BSc; Email: celine.joris@hug.ch

Study Locations

• Switzerland
  • Canton of Geneva
    • Geneva, Canton of Geneva, Switzerland, 1211
      • Recruiting
      • Geneva University Hospitals
      • Sub-Investigator: Charna Dibner, PhD
      • Contact: Tinh-Hai Collet, MD; Phone Number: +41-22-372 91 92; Email: tinh-hai.collet@hug.ch
      • Sub-Investigator: Isabelle Streuli, MD
      • Sub-Investigator: Anita Wolfer, MD, PhD
      • Sub-Investigator: Alexandre Bodmer, MD
      • Sub-Investigator: Emmanuel Biver, MD, PhD
      • Sub-Investigator: Maria Papageorgiou, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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
• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active Control	Behavioral: Active Control; Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities
Experimental: Time-Restricted Eating	Behavioral: 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.; Other Names: TRE 16h/8h

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in menopause / climacteric symptoms	Assessed by questionnaire	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)	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	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	From randomization visit to close-out visit (12 weeks)
Changes in joint pain	Joint pain assessed by questionnaire (0 = absent to 7 = Extremely bothered)	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)	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	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	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	From randomization visit to close-out visit (12 weeks)
Changes in fasting plasma glucose	Measured (in mmol/L) by clinical chemistry	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	From randomization visit to close-out visit (12 weeks)
Changes in lean body mass	Measured (in Kg) by dual-energy x-ray absorptiometry (DXA)	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)	From randomization visit to close-out visit (12 weeks)
Changes in muscle function	Measured (in Kg) by handgrip strength	From randomization visit to close-out visit (12 weeks)
Changes in glucose excursion	Measured by continuous glucose monitoring	From randomization visit to close-out visit (12 weeks)
Changes in metabolomic profile	Measured by high-throughput mass spectrometry metabolomics	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)	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	From randomization visit to close-out visit (12 weeks)
Changes in sleep duration	Measured by actigraphy	From randomization visit to close-out visit (12 weeks)
Changes in body temperature	Measured by body temperature wearable device	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)]	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	From randomization visit to close-out visit (12 weeks)

Collaborators and Investigators

• Sponsor: University Hospital, Geneva

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: February 15, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 4, 2025

Study Record Updates

• Last Update Posted (Actual): January 27, 2026
• Last Update Submitted That Met QC Criteria: January 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Disaccharidases; Trehalase
• Other Study ID Numbers: 2024-01257

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No