NCT03241121

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 235 (actual)
• Sponsor: University of Lausanne Hospitals · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Eating Behavior
• Metabolic Syndrome
• Obesity
• Dyslipidemias
• Glucose Intolerance
• Steatosis of Liver

Interventions

Type	Name	Description
BEHAVIORAL	Time restricted feeding	To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake
BEHAVIORAL	Regular dietary advices	Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines
DEVICE	Eating patterns	Data collection on eating patterns via the smartphone app

Timeline

• Start date: 2017-09-29
• Primary completion: 2021-03-31
• Completion: 2022-03-31
• First posted: 2017-08-07
• Last updated: 2024-12-06

Locations

2 sites across 1 country: Switzerland