Obesity Clinical Trial
Official title:
Study of Eating Patterns With a Smartphone App and the Metabolic Effects of Time Restricted Feeding (TRF) in the Metabolic Syndrome - An Open-label Randomized Controlled Trial of TRF vs Regular Dietary Advices
Verified date | May 2022 |
Source | University of Lausanne Hospitals |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
SwissChronoFood - Study of eating patterns with a smartphone app and the metabolic effects of time restricted feeding in metabolic syndrome The purpose of this study is to assess eating patterns among teenagers and adults with a new method, going beyond the pen-and-paper food diaries, and to investigate whether time restricted feeding leads to weight loss, improvement in lipid and glucose metabolism in individuals with components of the metabolic syndrome
Status | Completed |
Enrollment | 235 |
Est. completion date | March 31, 2022 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 12 Years and older |
Eligibility | Key inclusion criteria for both observation and intervention phases (Part 1+2): - Age = 12 years - Body mass index = 20 kg/m2 and stable weight (previous 3 months) in adults; BMI = 25th percentile in teenagers - Smartphone compatible with the app (iOS or Android systems) Additional inclusion criteria for the intervention phase (Part 2): - Any component of the metabolic syndrome following the International Diabetes Federation consensus definition - Eating duration >14h during the observation phase Additional inclusion criteria for the mechanistic study (Part 3): - Age 18-40 years, men and pre-menopausal women - BMI 30-40 kg/m2 - In the fasting state (at least 8 hours) Key exclusion criteria for both observation and intervention phases (Part 1+2): - Pregnant and breastfeeding women, plans for maternity during the study - Major illness/fever over the previous month, active cancer - Eating disorder, on a diet / weight management, prior bariatric surgery - Major mental illness, unable to give informed consent - Current shift work or travel abroad planned in the next month Additional exclusion criteria for the intervention phase (Part 2): - Prior cardiovascular event - Major liver, gastrointestinal, renal or endocrine disorder, diabetes mellitus with hypoglycemic drug(s) - Major sleep disorder, centrally acting medication - Lipid lowering drug, hypoglycemic drug, medication affecting the gut Additional exclusion criteria for the mechanistic study (Part 3): - Impaired glucose tolerance (pre-diabetes) or diabetes mellitus - Positive pregnancy test |
Country | Name | City | State |
---|---|---|---|
Switzerland | Inselspital, Klinik für Allgemeine Innere Medizin | Bern | BE |
Switzerland | University Hospital of Lausanne (CHUV) | Lausanne |
Lead Sponsor | Collaborator |
---|---|
University of Lausanne Hospitals | Salk Institute for Biological Studies |
Switzerland,
Borloz S, Bucher Della Torre S, Collet TH, Jotterand Chaparro C. Consumption of Ultraprocessed Foods in a Sample of Adolescents With Obesity and Its Association With the Food Educational Style of Their Parent: Observational Study. JMIR Pediatr Parent. 202 — View Citation
Papageorgiou M, Biver E, Mareschal J, Phillips NE, Hemmer A, Biolley E, Schwab N, Manoogian ENC, Gonzalez Rodriguez E, Aeberli D, Hans D, Pot C, Panda S, Rodondi N, Ferrari SL, Collet TH. The effects of time-restricted eating and weight loss on bone metab — View Citation
Phillips NE, Mareschal J, Schwab N, Manoogian ENC, Borloz S, Ostinelli G, Gauthier-Jaques A, Umwali S, Gonzalez Rodriguez E, Aeberli D, Hans D, Panda S, Rodondi N, Naef F, Collet TH. The Effects of Time-Restricted Eating versus Standard Dietary Advice on — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in fat mass | Body composition as measured by dual energy X-ray absorptiometry (DEXA) | From randomization visit to close-out visit (Part 3: 6 months, only adults) | |
Other | Change in fat free mass | Body composition as measured by dual energy X-ray absorptiometry (DEXA) | From randomization visit to close-out visit (Part 3: 6 months, only adults) | |
Other | Change in diurnal rhythms of cortisol secretion | Repeated measurements of cortisol over a 24-hour cycle | From randomization visit to close-out visit (Part 3: 6 months, only adults) | |
Other | Change in diurnal rhythms of melatonin secretion | Repeated measurements of melatonin over a 24-hour cycle | From randomization visit to close-out visit (Part 3: 6 months, only adults) | |
Other | Change in physical activity | As measured by actigraphy | From randomization visit to close-out visit (Part 3: 6 months, only adults) | |
Other | Change in sleep/wake cycles | As measured by actigraphy | From randomization visit to close-out visit (Part 3: 6 months, only adults) | |
Other | Eating duration - alternative definition of the primary outcome | Alternative definition of eating duration accounting for 2.5-97.5th percentiles of caloric intake over 24 hours, presumably less sensitive to the occasionally forgotten food picture event | From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers) | |
Primary | Eating duration | Duration from the first to last caloric intake over 24-hour cycle, collected via the smartphone app.
Note: Key inclusion criterion for the intervention phase (Part 2). |
From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers) | |
Primary | Change of metabolic syndrome components | Number of participants with changes in weight and/or lipid profile and/or glucose metabolism in the intervention phase (Part 2).
Note: Changes of the different components will be analyzed separately as secondary outcomes. |
From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Adherence to TRF intervention | After allocation to the TRF arm, assessment of the adherence to the intervention, as measured by eating duration from the first to last caloric intake over 24-hour cycle. | From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Weight change | Part of the composite primary outcome in the intervention phase (Part 2) | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in lipid profile | Part of the composite primary outcome in the intervention phase (Part 2) | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in glucose metabolism | Part of the composite primary outcome in the intervention phase (Part 2) | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in blood pressure | Systolic and diastolic blood pressure | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in hepatic steatosis / fibrosis score | As measured by the Fibroscan device | From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in number of meals per day | Temporal analysis of caloric intake events collected by the smartphone app | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in meal intervals | Temporal analysis of caloric intake events collected by the smartphone app | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in fraction of calories consumed after noon | Estimation of caloric content from food pictures collected by the smartphone app | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in fraction of calories consumed after 6pm | Estimation of caloric content from food pictures collected by the smartphone app | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) | |
Secondary | Change in eating pattern difference between weekdays and weekends | Indirect assessment of different lifestyle habits during weekdays and weekends | From baseline visit to close-out visit (Part 1: 4 weeks for adults, 2 weeks for teenagers; followed by Part 2: 6 months for adults, 6 weeks for teenagers) |
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