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

• ClinicalTrials.gov Identifier: NCT03241121
• Recruitment Status: Active, not recruiting
• First Posted: August 7, 2017
• Last Update Posted: October 22, 2020
• Sponsor: University of Lausanne Hospitals
• Collaborator: Salk Institute for Biological Studies
• Information provided by (Responsible Party): Tinh-Hai Collet, MD, University of Lausanne Hospitals

Tracking Information

• First Submitted Date: April 2, 2017
• First Posted Date: August 7, 2017
• Last Update Posted Date: October 22, 2020
• Actual Study Start Date: September 29, 2017
• Actual Primary Completion Date: August 25, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 28, 2019)

• Eating duration [ Time Frame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers) ]
  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).
• Change of metabolic syndrome components [ Time Frame: 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) ]
  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.

Original Primary Outcome Measures (submitted: August 2, 2017)

• Eating duration [ Time Frame: From baseline visit to end of observation phase (Part 1: 4 weeks) ]
  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).
• Change of metabolic syndrome components [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  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.

Current Secondary Outcome Measures (submitted: May 28, 2019)

• Adherence to TRF intervention [ Time Frame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers) ]
  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.
• Weight change [ Time Frame: 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) ]
  Part of the composite primary outcome in the intervention phase (Part 2)
• Change in lipid profile [ Time Frame: 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) ]
  Part of the composite primary outcome in the intervention phase (Part 2)
• Change in glucose metabolism [ Time Frame: 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) ]
  Part of the composite primary outcome in the intervention phase (Part 2)
• Change in blood pressure [ Time Frame: 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) ]
  Systolic and diastolic blood pressure
• Change in hepatic steatosis / fibrosis score [ Time Frame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers) ]
  As measured by the Fibroscan device
• Change in number of meals per day [ Time Frame: 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) ]
  Temporal analysis of caloric intake events collected by the smartphone app
• Change in meal intervals [ Time Frame: 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) ]
  Temporal analysis of caloric intake events collected by the smartphone app
• Change in fraction of calories consumed after noon [ Time Frame: 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) ]
  Estimation of caloric content from food pictures collected by the smartphone app
• Change in fraction of calories consumed after 6pm [ Time Frame: 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) ]
  Estimation of caloric content from food pictures collected by the smartphone app
• Change in eating pattern difference between weekdays and weekends [ Time Frame: 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) ]
  Indirect assessment of different lifestyle habits during weekdays and weekends

Original Secondary Outcome Measures (submitted: August 2, 2017)

• Adherence to TRF intervention [ Time Frame: From randomization visit to close-out visit (Part 2: 6 months) ]
  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.
• Weight change [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Part of the composite primary outcome in the intervention phase (Part 2)
• Change in lipid profile [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Part of the composite primary outcome in the intervention phase (Part 2)
• Change in glucose metabolism [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Part of the composite primary outcome in the intervention phase (Part 2)
• Change in blood pressure [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Systolic and diastolic blood pressure
• Change in hepatic steatosis / fibrosis score [ Time Frame: From randomization visit to close-out visit (Part 2: 6 months) ]
  As measured by the Fibroscan device
• Change in number of meals per day [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Temporal analysis of caloric intake events collected by the smartphone app
• Change in meal intervals [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Temporal analysis of caloric intake events collected by the smartphone app
• Change in fraction of calories consumed after noon [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Estimation of caloric content from food pictures collected by the smartphone app
• Change in fraction of calories consumed after 6pm [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Estimation of caloric content from food pictures collected by the smartphone app
• Change in eating pattern difference between weekdays and weekends [ Time Frame: From baseline visit to close-out visit (Part 1: 4 weeks + Part 2: 6 months) ]
  Indirect assessment of different lifestyle habits during weekdays and weekends

Current Other Pre-specified Outcome Measures (submitted: May 28, 2019)

• Change in fat mass [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults) ]
  Body composition as measured by dual energy X-ray absorptiometry (DEXA)
• Change in fat free mass [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults) ]
  Body composition as measured by dual energy X-ray absorptiometry (DEXA)
• Change in diurnal rhythms of cortisol secretion [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults) ]
  Repeated measurements of cortisol over a 24-hour cycle
• Change in diurnal rhythms of melatonin secretion [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults) ]
  Repeated measurements of melatonin over a 24-hour cycle
• Change in physical activity [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults) ]
  As measured by actigraphy
• Change in sleep/wake cycles [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months, only adults) ]
  As measured by actigraphy
• Eating duration - alternative definition of the primary outcome [ Time Frame: From baseline visit to end of observation phase (Part 1: 4 weeks for adults, 2 weeks for teenagers) ]
  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

Original Other Pre-specified Outcome Measures (submitted: August 2, 2017)

• Change in fat mass [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months) ]
  Body composition as measured by dual energy X-ray absorptiometry (DEXA)
• Change in fat free mass [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months) ]
  Body composition as measured by dual energy X-ray absorptiometry (DEXA)
• Change in diurnal rhythms of cortisol secretion [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months) ]
  Repeated measurements of cortisol over a 24-hour cycle
• Change in diurnal rhythms of melatonin secretion [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months) ]
  Repeated measurements of melatonin over a 24-hour cycle
• Change in physical activity [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months) ]
  As measured by actigraphy
• Change in sleep/wake cycles [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months) ]
  As measured by actigraphy
• Eating duration - alternative definition of the primary outcome [ Time Frame: From baseline visit to end of observation phase (Part 1: 4 weeks) ]
  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

Descriptive Information

• Brief Title: 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

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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

Study Part 1: Prospective longitudinal observational study. Study Part 2/3: Open-label randomized controlled trial.

Masking: None (Open Label)
Primary Purpose: Treatment

Condition

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

Intervention

• 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

Study Arms

• Experimental: Time restricted feeding
  For those in the intervention phase (Part 2)
  Interventions:

  • Behavioral: Time restricted feeding
  • Device: Eating patterns
• Active Comparator: Regular dietary advices
  For those in the intervention phase (Part 2)
  Interventions:

  • Behavioral: Regular dietary advices
  • Device: Eating patterns

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Estimated Enrollment (submitted: August 2, 2017): 500
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 2021
• Actual Primary Completion Date: August 25, 2020 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT03241121
• Other Study ID Numbers: 2017-00487; PZ00P3-167826 ( Other Grant/Funding Number: Swiss National Science Foundation ); SSED-YI 2017 ( Other Grant/Funding Number: Swiss Society of Endocrinology and Diabetes )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol
• Time Frame: Starting 6 months after publication
• Access Criteria: Upon appropriate data request by other scientists

• Responsible Party: Tinh-Hai Collet, MD, University of Lausanne Hospitals
• Study Sponsor: University of Lausanne Hospitals
• Collaborators: Salk Institute for Biological Studies

Investigators

• Principal Investigator: Tinh-Hai Collet, MD; University of Lausanne Hospitals

• PRS Account: University of Lausanne Hospitals
• Verification Date: October 2020