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

Overview

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.

Interventions

• 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.
• Behavioral Active Control
  Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities

Primary outcome measures

• Changes in body weight [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in body fat mass [Time frame: From randomization visit to close-out visit (12 weeks)]

Secondary outcome measures (12)

• Changes in menopause / climacteric symptoms [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in bone mineral density [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in bone turnover marker CTX [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in bone turnover marker P1NP [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in joint pain [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in body mass index (BMI) [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in waist circumference [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in hip circumference [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in systolic and diastolic blood pressure [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in fasting plasma glucose [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in lipid profile [Time frame: From randomization visit to close-out visit (12 weeks)]
• Changes in lean body mass [Time frame: From randomization visit to close-out visit (12 weeks)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• Geneva University Hospitals — Geneva

Identifiers

NCT: NCT06855784 · 2024-01257

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗