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

• Register: ClinicalTrials.gov
• Last refreshed on: 31 October 2022
• Main ID: NCT03241121
• Date of registration: 02/04/2017
• Prospective Registration: Yes
• Primary sponsor: University of Lausanne Hospitals
• Public title: Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome
• Scientific 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
• Date of first enrolment: September 29, 2017
• Target sample size: 235
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03241121
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Switzerland

Contacts

• Name: Tinh-Hai Collet, MD
• Affiliation: University of Lausanne Hospitals

Key inclusion & exclusion 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



Age minimum: 12 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Steatosis of Liver

Eating Behavior

Obesity

Dyslipidemias

Glucose Intolerance

Metabolic Syndrome

Intervention(s)

Device: Eating patterns

Behavioral: Time restricted feeding

Behavioral: Regular dietary advices

Primary Outcome(s)

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)]

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

Secondary Outcome(s)

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)]

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)]

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)]

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)]

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)]

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)]

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)]

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)]

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)]

Adherence to TRF intervention [Time Frame: From randomization visit to close-out visit (Part 2: 6 months for adults, 6 weeks for teenagers)]

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)]

Secondary ID(s)

PZ00P3-167826

2017-00487

SSED-YI 2017

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Salk Institute for Biological Studies