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

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

Study Overview

• Status: Completed
• Conditions: Obesity; Metabolic Syndrome; Dyslipidemias; Glucose Intolerance; Eating Behavior; Steatosis of Liver
• Intervention / Treatment: Behavioral: Time restricted feeding; Device: Eating patterns; Behavioral: Regular dietary advices

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.

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • University Hospital of Lausanne (CHUV)
  • BE
    • Bern, BE, Switzerland, 3010
      • Inselspital, Klinik für Allgemeine Innere Medizin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Time restricted feeding; For those in the intervention phase (Part 2)	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; Device: Eating patterns; Data collection on eating patterns via the smartphone app
ACTIVE_COMPARATOR: Regular dietary advices; For those in the intervention phase (Part 2)	Device: Eating patterns; Data collection on eating patterns via the smartphone app; Behavioral: Regular dietary advices; Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines

What is the study measuring?

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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
Change in physical activity	As measured by actigraphy	From randomization visit to close-out visit (Part 3: 6 months, only adults)
Change in sleep/wake cycles	As measured by actigraphy	From randomization visit to close-out visit (Part 3: 6 months, only adults)
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)

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Collaborators: Salk Institute for Biological Studies
• Investigators: Principal Investigator: Tinh-Hai Collet, MD, University of Lausanne Hospitals

Publications and helpful links

General Publications

• 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.
• 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.
• 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 1:85-95. doi: 10.1002/oby.23577. Epub 2022 Oct 14.

Helpful Links

• Study website

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 29, 2017
• Primary Completion (ACTUAL): March 31, 2021
• Study Completion (ACTUAL): March 31, 2022

Study Registration Dates

• First Submitted: April 2, 2017
• First Submitted That Met QC Criteria: August 2, 2017
• First Posted (ACTUAL): August 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 20, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Time Restricted Feeding; Eating patterns
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Liver Diseases; Insulin Resistance; Hyperinsulinism; Hyperglycemia; Lipid Metabolism Disorders; Syndrome; Fatty Liver; Metabolic Syndrome; Glucose Intolerance; Dyslipidemias
• Other Study ID Numbers: 2017-00487; PZ00P3-167826 (OTHER_GRANT: Swiss National Science Foundation); SSED-YI 2017 (OTHER_GRANT: Swiss Society of Endocrinology and Diabetes)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized dataset of selected variables that underlie results in a publication. Some data may not be amenable to complete anonymization and will not be shared to ensure appropriate confidentiality of participant's data.
• IPD Sharing Time Frame: Starting 6 months after publication
• IPD Sharing Access Criteria: Upon appropriate data request by other scientists
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No