Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age45-60
SponsorUniversity Hospital, Geneva
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Time-Restricted Eating 16h/8h
BehavioralParticipants 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.
Active Control
BehavioralParticipants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities
Treatment groups
84 Participants
are divided into 2 treatment groupsGroup A: Time-Restricted EatingExperimental treatment 1 intervention
Group B: Active ControlActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Changes in body weight
Measured (in Kg) in light clothing using a calibrated medical-grade scale
Time frame
From randomization visit to close-out visit (12 weeks)2
Changes in body fat mass
Measured (in Kg) by dual-energy x-ray absorptiometry (DXA)
Time frame
From randomization visit to close-out visit (12 weeks)Secondary outcomes
1
Changes in menopause / climacteric symptoms
Assessed by questionnaire
Time frame
From randomization visit to close-out visit (12 weeks)2
Changes in bone mineral density
Measured (in g/cm3) by dual-energy x-ray absorptiometry (DXA)
Time frame
From randomization visit to close-out visit (12 weeks)3
Changes in bone turnover marker CTX
C-telopeptide cross-linked type 1 collagen (CTX) measured (in ng/L) by clinical chemistry
Time frame
From randomization visit to close-out visit (12 weeks)4
Changes in bone turnover marker P1NP
Procollagen type 1 N-terminal propeptide (P1NP) measured (in μg/L) by clinical chemistry
Time frame
From randomization visit to close-out visit (12 weeks)Sponsors and contacts
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Source ClinicalTrials.gov