Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome

Study Overview
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Brief Summary
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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

Detailed Description
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The prevalence of the metabolic syndrome (MS) is increasing worldwide, due to the progression of its different components (central obesity, elevated blood pressure, impaired glucose tolerance and dyslipidemia), as well as the often associated liver steatosis. One way to tackle the obesity epidemic is to intervene early at the onset in childhood and teenage years - before cardio-metabolic complications have occurred. However, lifestyle programs targeting this age group had limited success in the current obesogenic environment. In particular, weight loss is a key factor in controlling all MS components, yet it is difficult to maintain over time. Time restricted feeding (TRF) is an approach that emphasizes energy intake limited to certain windows of time within the 24-hour cycle without restrictions on calories or macronutrients. This has emerged as an appealing approach to reduce body weight while improving lipid profile and glucose metabolism. However, TRF has been mostly studied in animals and long-term prospective data on its efficacy and mechanisms in humans is lacking. Prior to the intervention, the investigators will assess the eating patterns of participants with an innovative smartphone application ('app') which is less intrusive and more reliable than food diaries/questionnaires to assess eating behavior and patterns. In this project, the investigators will assess eating patterns among teenagers and adults, and investigate whether a controlled TRF intervention leads to beneficial changes in MS components. Study Part 1 uses an epidemiological approach to establish baseline daily eating behavior, physical activity patterns and sleeping habits over 2 weeks (teenagers) and 4 weeks (adults) using the smartphone app. Those individuals meeting criteria for at least one component of MS and who have eaten for >14 hours per 24-hour cycle will be recruited for Study Part 2. In Part 2, participants will be assigned to TRF or active control groups, and followed in this pragmatic randomized controlled trial for 6 weeks (teenagers) and 6 months (adults) to assess the change in their weight and MS components, as well as liver fat deposits. Study Part 3 will investigate the underlying mechanisms of improved metabolic profile with TRF.

Official Title
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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

Conditions
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Eating Behavior, Obesity, Metabolic Syndrome, Dyslipidemias, Glucose Intolerance, Steatosis of Liver

Intervention / Treatment
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* Behavioral: Time restricted feeding
* Behavioral: Regular dietary advices
* Device: Eating patterns


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Study Part 1: Prospective longitudinal observational study. Study Part 2/3: Open-label randomized controlled trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Time restricted feeding<br>For those in the intervention phase (Part 2) | Behavioral: Time restricted feeding<br>* To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake<br>Device: Eating patterns<br>* Data collection on eating patterns via the smartphone app<br>|
| Active Comparator: Regular dietary advices<br>For those in the intervention phase (Part 2) | Behavioral: Regular dietary advices<br>* Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines<br>Device: Eating patterns<br>* Data collection on eating patterns via the smartphone app<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eating patterns, Time Restricted Feeding