Study of Eating Patterns with a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
NCT ID: NCT03241121
Last Updated: 2024-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
235 participants
INTERVENTIONAL
2017-09-29
2022-03-31
Brief Summary
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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
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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
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Time restricted feeding
For those in the intervention phase (Part 2)
Time restricted feeding
To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake
Eating patterns
Data collection on eating patterns via the smartphone app
Regular dietary advices
For those in the intervention phase (Part 2)
Regular dietary advices
Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines
Eating patterns
Data collection on eating patterns via the smartphone app
Interventions
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Time restricted feeding
To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake
Regular dietary advices
Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines
Eating patterns
Data collection on eating patterns via the smartphone app
Eligibility Criteria
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Inclusion Criteria
* 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)
* Any component of the metabolic syndrome following the International Diabetes Federation consensus definition
* Eating duration \>14h during the observation phase
* Age 18-40 years, men and pre-menopausal women
* BMI 30-40 kg/m2
* In the fasting state (at least 8 hours)
Exclusion Criteria
* 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
* 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
* Impaired glucose tolerance (pre-diabetes) or diabetes mellitus
* Positive pregnancy test
12 Years
ALL
Yes
Sponsors
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Salk Institute for Biological Studies
OTHER
University of Lausanne Hospitals
OTHER
Responsible Party
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Tinh-Hai Collet, MD
Principal Investigator
Principal Investigators
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Tinh-Hai Collet, MD
Role: PRINCIPAL_INVESTIGATOR
University of Lausanne Hospitals
Locations
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Inselspital, Klinik für Allgemeine Innere Medizin
Bern, Canton of Bern, Switzerland
University Hospital of Lausanne (CHUV)
Lausanne, , Switzerland
Countries
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References
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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.
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(Suppl 1):85-95. doi: 10.1002/oby.23577. Epub 2022 Oct 14.
Other Identifiers
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PZ00P3-167826
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
SSED-YI 2017
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
2017-00487
Identifier Type: -
Identifier Source: org_study_id