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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03241121
• Other study ID #: 2017-00487
• Secondary ID: PZ00P3-167826SSE
• Status: Completed
• Phase: N/A
• Start date: September 29, 2017
• Est. completion date: March 31, 2022

Study information

• Verified date: May 2022
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: March 31, 2022
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

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
• 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

Locations

Country	Name	City	State
Switzerland	Inselspital, Klinik für Allgemeine Innere Medizin	Bern	BE
Switzerland	University Hospital of Lausanne (CHUV)	Lausanne

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Salk Institute for Biological Studies

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. 202 — View 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 metab — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Other	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)
Other	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)
Other	Change in physical activity	As measured by actigraphy	From randomization visit to close-out visit (Part 3: 6 months, only adults)
Other	Change in sleep/wake cycles	As measured by actigraphy	From randomization visit to close-out visit (Part 3: 6 months, only adults)
Other	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)

External Links

•   Study website