ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03241121
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : October 26, 2017
Sponsor:
Collaborator:
Salk Institute for Biological Studies
Information provided by (Responsible Party):
Tinh-Hai Collet, MD, University of Lausanne Hospitals

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 metabolic syndrome


Condition or disease Intervention/treatment Phase
Eating Behavior Metabolic Syndrome Obesity Dyslipidemias Glucose Intolerance Steatosis of Liver Behavioral: Time restricted feeding Behavioral: Regular dietary advices Device: Eating patterns Not Applicable

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. Study Part 1 uses an epidemiological approach to establish baseline daily eating behavior, physical activity patterns and sleeping habits of teenagers and adults over 4 weeks using the smartphone app. Those individuals meeting international criteria for 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 months 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  (Clinical Trial)
Estimated Enrollment : 500 participants
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
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
Actual Study Start Date : September 29, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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)
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




Primary Outcome Measures :
  1. 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).


  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.



Secondary Outcome Measures :
  1. 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.

  2. 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)

  3. 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)

  4. 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)

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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


Other Outcome Measures:
  1. 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)

  2. 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)

  3. 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

  4. 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

  5. Change in physical activity [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months) ]
    As measured by actigraphy

  6. Change in sleep/wake cycles [ Time Frame: From randomization visit to close-out visit (Part 3: 6 months) ]
    As measured by actigraphy

  7. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  • Smartphone compatible with the app (iOS or Android systems)

Additional inclusion criteria for the intervention phase (Part 2):

  • 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
  • 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)
  • Positive pregnancy test

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03241121


Contacts
Contact: Tinh-Hai Collet, MD +41-21-3147955 tinh-hai.collet@chuv.ch
Contact: Nelly Pitteloud, MD +41-21-3140600 nelly.pitteloud@chuv.ch

Locations
Switzerland
University Hospital of Lausanne (CHUV) Recruiting
Lausanne, Switzerland, 1011
Contact: Tinh-Hai Collet, MD       tinh-hai.collet@chuv.ch   
Sponsors and Collaborators
University of Lausanne Hospitals
Salk Institute for Biological Studies
Investigators
Principal Investigator: Tinh-Hai Collet, MD University of Lausanne Hospitals

Responsible Party: Tinh-Hai Collet, MD, Principal Investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT03241121     History of Changes
Other Study ID Numbers: 2017-00487
PZ00P3-167826 ( Other Grant/Funding Number: Swiss National Science Foundation )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (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

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

Keywords provided by Tinh-Hai Collet, MD, University of Lausanne Hospitals:
Time Restricted Feeding
Eating patterns

Additional relevant MeSH terms:
Syndrome
Metabolic Syndrome X
Dyslipidemias
Glucose Intolerance
Fatty Liver
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Lipid Metabolism Disorders
Hyperglycemia
Liver Diseases
Digestive System Diseases