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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Time-Restricted Eating | Experimental |
| |
| Active Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Time-Restricted Eating 16h/8h | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in body weight | Measured (in Kg) in light clothing using a calibrated medical-grade scale | From randomization visit to close-out visit (12 weeks) |
| Changes in body fat mass | Measured (in Kg) by dual-energy x-ray absorptiometry (DXA) | From randomization visit to close-out visit (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in menopause / climacteric symptoms | Assessed by questionnaire | From randomization visit to close-out visit (12 weeks) |
| Changes in bone mineral density | Measured (in g/cm3) by dual-energy x-ray absorptiometry (DXA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tinh-Hai Collet, MD | Contact | +41-22-372 91 92 | tinh-hai.collet@hug.ch | |
| Céline Joris, BSc | Contact | celine.joris@hug.ch |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geneva University Hospitals | Recruiting | Geneva | Canton of Geneva | 1211 | Switzerland |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D014198 | Trehalase |
| ID | Term |
|---|---|
| D004186 | Disaccharidases |
| D006026 | Glycoside Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
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|
| Active Control | Behavioral | Participants will be advised to eat 2 to 3 meals every day according to their eating habits and social activities |
|
| From randomization visit to close-out visit (12 weeks) |
| Changes in bone turnover marker CTX | C-telopeptide cross-linked type 1 collagen (CTX) measured (in ng/L) by clinical chemistry | From randomization visit to close-out visit (12 weeks) |
| Changes in bone turnover marker P1NP | Procollagen type 1 N-terminal propeptide (P1NP) measured (in μg/L) by clinical chemistry | From randomization visit to close-out visit (12 weeks) |
| Changes in joint pain | Joint pain assessed by questionnaire (0 = absent to 7 = Extremely bothered) | From randomization visit to close-out visit (12 weeks) |
| Changes in body mass index (BMI) | Expressed in percent of baseline value (body mass index = weight in Kg divided by the height in meters squared, unit Kg/m2) | From randomization visit to close-out visit (12 weeks) |
| Changes in waist circumference | Measured (in cm) with a measuring tape, following the WHO 2008 Expert Report | From randomization visit to close-out visit (12 weeks) |
| Changes in hip circumference | Measured (in cm) with a measuring tape, following the WHO 2008 Expert Report | From randomization visit to close-out visit (12 weeks) |
| Changes in systolic and diastolic blood pressure | Measured (in mmHg) with an arm cuff in the sitting position | From randomization visit to close-out visit (12 weeks) |
| Changes in fasting plasma glucose | Measured (in mmol/L) by clinical chemistry | From randomization visit to close-out visit (12 weeks) |
| Changes in lipid profile | Total cholesterol, LDL cholesterol, triglycerides and HDL cholesterol concentrations measured (in mmol/L) by clinical chemistry | From randomization visit to close-out visit (12 weeks) |
| Changes in lean body mass | Measured (in Kg) by dual-energy x-ray absorptiometry (DXA) | From randomization visit to close-out visit (12 weeks) |
| Changes in body composition | Fat mass and fat-free mass (in Kg) measured by bioelectrical impedance analysis (BIA) | From randomization visit to close-out visit (12 weeks) |
| Changes in muscle function | Measured (in Kg) by handgrip strength | From randomization visit to close-out visit (12 weeks) |
| Changes in glucose excursion | Measured by continuous glucose monitoring | From randomization visit to close-out visit (12 weeks) |
| Changes in metabolomic profile | Measured by high-throughput mass spectrometry metabolomics | From randomization visit to close-out visit (12 weeks) |
| Changes in physical activity | Measured by actigraphy (in activity counts, CamNTech proprietary algorithm) and by the International Physical Activity Questionnaire (IPAQ, aggregated in MET-minutes/week) | From randomization visit to close-out visit (12 weeks) |
| Changes in sleep/wake cycles | Measured by actigraphy assessed as time of sleep onset and wake-up in 24-hour cycle | From randomization visit to close-out visit (12 weeks) |
| Changes in sleep duration | Measured by actigraphy | From randomization visit to close-out visit (12 weeks) |
| Changes in body temperature | Measured by body temperature wearable device | From randomization visit to close-out visit (12 weeks) |
| Changes in sleep quality | Assessed by the Pittsburgh Sleep Quality Index [PSQI, minimum score = 0 (better); maximum score = 21 (worse)] | From randomization visit to close-out visit (12 weeks) |
| Changes in eating duration | Duration from the first to last caloric intake over 24-hour cycle | From randomization visit to close-out visit (12 weeks) |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D045762 |
| Enzymes and Coenzymes |