Status:
COMPLETED
Study of Eating Patterns with a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
Lead Sponsor:
University of Lausanne Hospitals
Collaborating Sponsors:
Salk Institute for Biological Studies
Conditions:
Eating Behavior
Metabolic Syndrome
Eligibility:
All Genders
12+ years
Phase:
NA
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 amon...
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 dysl...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
September 29 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2022
Estimated Enrollment :
235 Patients enrolled
Trial Details
Trial ID
NCT03241121
Start Date
September 29 2017
End Date
March 31 2022
Last Update
December 6 2024
Active Locations (2)
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1
Inselspital, Klinik für Allgemeine Innere Medizin
Bern, Canton of Bern, Switzerland, 3010
2
University Hospital of Lausanne (CHUV)
Lausanne, Switzerland, 1011