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

Phase

N/A

Condition

Menopause

Diabetes Prevention

Obesity

Treatment

Active Control

Time-Restricted Eating 16h/8h

Clinical Study ID

NCT06855784

2024-01257

Ages 45-60
Female

Study 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

Inclusion Criteria:

Women with confirmed physiological menopause without current anti-cancer treatment (group A), or women with menopausal symptoms in the context of aromatase inhibitorsused as adjuvant therapy for hormone-sensitive non-metastatic breast cancersregardless 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 entireduration
Confident use of a smartphone and able to take regular pictures of food/drinks

Exclusion

Exclusion Criteria:

On a hypocaloric restrictive diet, intermittent fasting or in a weight managementprogram 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 ofhypoglycemia (i.e. treated with non-hypoglycemic drugs or without medication) willbe included
Active metabolic bone diseases (e.g. Paget disease, osteomalacia), however womenwith 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 2weeks or planned during the study
Enrolled in another interventional clinical trial (medication, surgery, medicaldevice) over the previous 2 weeks or planned during the study

Study Design