Intermittent fasting to improve body composition and symptoms in menopause and hormone-sensitive breast cancer (TREMHO) – Randomized clinical trial without blinding
Résumé de l'étude
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 methods to slow down the weight gain frequently encountered in this situation, to reduce the intensity of menopausal symptoms, and to improve quality of life in this context. In this study, we examine the effectiveness and possible side effects of time-restricted eating (TRE) intermittent fasting (with food limited to 8 hours per day and alternating 16 hours of fasting) compared to a control group. Participation lasts 14 weeks, with an optional follow-up of 12 months from the start of the study. Participants will be randomly assigned to either the intervention group (intermittent fasting) or the control group. In the intervention group, a 16h/8h TRE intermittent fasting is practiced for 3 months. In the control group, the usual eating pattern is continued. The primary objective of the study is to assess the effectiveness of TRE intermittent fasting in terms of weight loss and fat mass, improvement of metabolic profile, menopausal symptoms, and bone health after menopause. We will closely monitor any potential adverse effects.
(BASEC)
Intervention étudiée
TRE intermittent fasting (time-restricted eating, with food limited to 8 hours per day and alternating 16 hours of fasting)
(BASEC)
Maladie en cours d'investigation
Physiological menopause or treatment-induced menopause following breast cancer
(BASEC)
- Women with confirmed early physiological menopause (Group A) or treatment-induced menopause from targeted hormonal therapy in the context of adjuvant chemotherapy for non-metastatic hormone-sensitive breast cancers (Group B) - Age 40-65 years - Body mass index 25-40 kg/m2 - Stable weight (+/- 2 kg) - Eating window ≥ 12 hours - Ability to provide informed consent and follow study procedures - Regular use of a smartphone and the app dedicated to the research project (BASEC)
Critères d'exclusion
- Restrictive hypocaloric diet, intermittent fasting, weight loss program, previous bariatric surgery - Eating disorders, psychiatric illness - Psychoactive treatment - Diabetes with hypoglycemic medication(s) - Metabolic bone diseases (e.g., Paget's disease, osteomalacia) - Night shift work, travel to another time zone (≥ 2 hours time difference) - Participation in another interventional clinical trial (drug, surgery, medical device) (BASEC)
Lieu de l’étude
Genève
(BASEC)
Sponsor
Hôpitaux Universitaires de Genève (HUG)
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof. Tinh-Hai Collet
+41-22-3729192
tinh-hai.collet@clutterhug.chHôpitaux Universitaires de Genève Service d'endocrinologie, diabétologie et métabolisme
(BASEC)
Informations générales
+41-22-372 91 92+41-22-372 91 92
tinh-hai.collet@clutterhug.chtinh-hai.collet@clutterhug.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale d'éthique de Genève
(BASEC)
Date d'approbation du comité d'éthique
13.12.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06855784 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Time-Restricted Eating to improve body composition and symptoms in Menopause and HOrmone-sensitive breast cancers (TREMHO study) – An open-label randomized controlled trial (BASEC)
Titre académique
Time-Restricted Eating to Improve Body Composition and Symptoms in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) - An Open-label Randomized Controlled Trial (ICTRP)
Titre public
Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) (ICTRP)
Maladie en cours d'investigation
MenopauseObesity and Overweight (ICTRP)
Intervention étudiée
Behavioral: Time-Restricted Eating 16h/8hBehavioral: Active Control (ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Critères d'inclusion/exclusion
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/drinksExclusion 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 (ICTRP)
non disponible
Critères d'évaluation principaux et secondaires
Changes in body weight;Changes in body fat mass (ICTRP)
Changes in menopause / climacteric symptoms;Changes in bone mineral density;Changes in bone turnover marker CTX;Changes in bone turnover marker P1NP;Changes in joint pain;Changes in body mass index (BMI);Changes in waist circumference;Changes in hip circumference;Changes in systolic and diastolic blood pressure;Changes in fasting plasma glucose;Changes in lipid profile;Changes in lean body mass;Changes in body composition;Changes in muscle function;Changes in glucose excursion;Changes in metabolomic profile;Changes in physical activity;Changes in sleep/wake cycles;Changes in sleep duration;Changes in body temperature;Changes in sleep quality;Changes in eating duration (ICTRP)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
non disponible
Contacts supplémentaires
Tinh-Hai Collet, MDTinh-Hai Collet, MD, tinh-hai.collet@hug.chtinh-hai.collet@hug.ch, +41-22-372 91 92+41-22-372 91 92 (ICTRP)
ID secondaires
2024-01257 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/study/NCT06855784 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible