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

NCT06855784 | Recruiting

• 1 other identifier: 2024-01257
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Menopause; Obesity and Overweight

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (22)

• Changes in menopause / climacteric symptoms

  From randomization visit to close-out visit (12 weeks)

• Changes in bone mineral density

  From randomization visit to close-out visit (12 weeks)

• Changes in bone turnover marker CTX

  From randomization visit to close-out visit (12 weeks)

• Changes in bone turnover marker P1NP

  From randomization visit to close-out visit (12 weeks)

• Changes in joint pain

  From randomization visit to close-out visit (12 weeks)

Study Arms (2)

Time-Restricted Eating

EXPERIMENTAL

Behavioral: Time-Restricted Eating 16h/8h

Active Control

ACTIVE COMPARATOR

Behavioral: Active Control

Interventions

Active Control BEHAVIORAL

Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities

Active Control

Time-Restricted Eating 16h/8h BEHAVIORAL

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.

Also known as: TRE 16h/8h

Time-Restricted Eating

Eligibility Criteria

• Age: 45 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Geneva University Hospitals

Geneva, Canton of Geneva, 1211, Switzerland

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Interventions

Trehalase

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Disaccharidases; Glycoside Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes

Central Study Contacts

Tinh-Hai Collet, MD

CONTACT

+41-22-372 91 92; tinh-hai.collet@hug.ch

Céline Joris, BSc

CONTACT

celine.joris@hug.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 15, 2025
• First Posted: March 4, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: January 27, 2026

Record last verified: 2026-01

Locations

CH (1)