Clinical trial NCT03241121: Study of Eating Patterns with a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Eating Behavior
Metabolic Syndrome
Obesity
Dyslipidemias
Glucose Intolerance
Steatosis of Liver
Keywords: Time Restricted Feeding
Eating patterns
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Salk Institute for Biological Studies
First posted: 2017-08-07
Enrollment: 235
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Study Part 1: Prospective longitudinal observational study. Study Part 2/3: Open-label randomized controlled trial.
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Eating duration
timeFrame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)
measure: Change of metabolic syndrome components
timeFrame: 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 outcomes:
measure: Adherence to TRF intervention
timeFrame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
measure: Weight change
timeFrame: 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)
measure: Change in lipid profile
timeFrame: 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)
measure: Change in glucose metabolism
timeFrame: 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)
measure: Change in blood pressure
timeFrame: 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)
measure: Change in hepatic steatosis / fibrosis score
timeFrame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)
measure: Change in number of meals per day
timeFrame: 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)
measure: Change in meal intervals
timeFrame: 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)
measure: Change in fraction of calories consumed after noon
timeFrame: 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)
measure: Change in fraction of calories consumed after 6pm
timeFrame: 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)
measure: Change in eating pattern difference between weekdays and weekends
timeFrame: 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)
Other outcomes:
measure: Change in fat mass
timeFrame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
measure: Change in fat free mass
timeFrame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
measure: Change in diurnal rhythms of cortisol secretion
timeFrame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
measure: Change in diurnal rhythms of melatonin secretion
timeFrame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
measure: Change in physical activity
timeFrame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
measure: Change in sleep/wake cycles
timeFrame: From randomization visit to close-out visit (Part 3: 6 months, only adults)
measure: Eating duration - alternative definition of the primary outcome
timeFrame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers)
Locations:
city: Bern
country: Switzerland
facility: Inselspital, Klinik für Allgemeine Innere Medizin
state: BE
city: Lausanne
country: Switzerland
facility: University Hospital of Lausanne (CHUV)
Study officials:
affiliation: University of Lausanne Hospitals
name: Tinh-Hai Collet, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Buso G, Favre L, Vionnet N, Gonzalez-Rodriguez E, Hans D, Puder JJ, Dubath C, Eap CB, Raffoul W, Collet TH, Mazzolai L. Body Composition Assessment by Dual-Energy X-Ray Absorptiometry: A Useful Tool for the Diagnosis of Lipedema. Obes Facts. 2022;15(6):762-773. doi: 10.1159/000527138. Epub 2022 Oct 28.
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 Weight, Metabolic Health and the Consumption of Processed Food: A Pragmatic Randomised Controlled Trial in Community-Based Adults. Nutrients. 2021 Mar 23;13(3):1042. doi: 10.3390/nu13031042.
citation: 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. 2021 Nov 15;4(4):e28608. doi: 10.2196/28608.
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 metabolism and health: a 6-month randomized controlled trial. Obesity (Silver Spring). 2023 Feb;31 Suppl 1(Suppl 1):85-95. doi: 10.1002/oby.23577. Epub 2022 Oct 14.