Intermittent fasting to improve body composition and symptoms in menopause and hormone-sensitive breast cancer (TREMHO) – Randomized clinical trial without blinding
Zusammenfassung der Studie
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)
Untersuchte Intervention
TRE intermittent fasting (time-restricted eating, with food limited to 8 hours per day and alternating 16 hours of fasting)
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
- 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)
Studienstandort
Genf
(BASEC)
Sponsor
Hôpitaux Universitaires de Genève (HUG)
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof. Tinh-Hai Collet
+41-22-3729192
tinh-hai.collet@clutterhug.chHôpitaux Universitaires de Genève Service d'endocrinologie, diabétologie et métabolisme
(BASEC)
Allgemeine Auskünfte
+41-22-372 91 92+41-22-372 91 92
tinh-hai.collet@clutterhug.chtinh-hai.collet@clutterhug.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Genf
(BASEC)
Datum der Bewilligung durch die Ethikkommission
13.12.2024
(BASEC)
ICTRP Studien-ID
NCT06855784 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
Time-Restricted Eating to Improve Body Composition and Symptoms in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) - An Open-label Randomized Controlled Trial (ICTRP)
Öffentlicher Titel
Time-Restricted Eating in Menopause and HOrmone-sensitive Breast Cancers (TREMHO) (ICTRP)
Untersuchte Krankheit(en)
MenopauseObesity and Overweight (ICTRP)
Untersuchte Intervention
Behavioral: Time-Restricted Eating 16h/8hBehavioral: Active Control (ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). (ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
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)
Sekundäre IDs
2024-01257 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/study/NCT06855784 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar