Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans

Study Overview
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Brief Summary
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This human dietary intervention study with a cross-over design aims to compare the effects of two isocaloric diets - early time-restricted feeding (TRF) vs. late TRF - on glycemic control and lipid metabolism in overweight and obese women.

Detailed Description
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The participants are randomly allocated to one of two study groups: In study group (A) participants will begin with the early TRF (e-TRF) intervention. They will consume their habitual food (and the habitual daily amount of food) between 8 am and 4 pm for two weeks. After a washout-phase participants will conduct the late TRF (l-TRF) and consume their habitual food between 1 pm and 9 pm for another two weeks. Study group (B) receives the same interventions in the reversed order. Both dietary regimens will result in 8-hr eating period and 16-hr fasting period during the 24h day.

Official Title
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Time-restricted Feeding as a Dietary Strategy Against Metabolic Disturbances in Humans

Conditions
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Overweight and Obesity

Intervention / Treatment
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* Behavioral: Early Time-Restricted Feeding
* Behavioral: Late Time-Restricted Feeding


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI 25-35 kg/m² Exclusion Criteria: prior diagnosis of type 1 or 2 diabetes weight changes > 5% within past 3 months current shift work or history of shift work traveled across more than one time zone one month before the study poor quality of sleep (PSQI score>10) eating disorders, food intolerance/allergy, severe indigestion Pregnant or breastfeeding severe internal or psychiatric disorders or other conditions that might influence the outcome of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early Time-Restricted Feeding<br> | Behavioral: Early Time-Restricted Feeding<br>* Eat between 8 am and 4 pm for two weeks<br>* Other names: eTRF;|
| Experimental: Late Time-Restricted Feeding<br> | Behavioral: Late Time-Restricted Feeding<br>* Eat between 1 pm and 9 pm for two weeks<br>* Other names: lTRF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity | Assessed using Matsuda index in oral glucose tolerance test (OGTT) | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance, fasting glucose, and overall daily glycemic variation | Assessed by glucose area under the curve in OGTT and using a continuous glucose monitoring system | 1-2 weeks | 
| Metabolic hormones and inflammatory markers | Levels of hormones related to the glucose metabolism, hormones of appetite regulation, adipokines and inflammatory markers | 2 weeks | 
| Blood lipids | Total cholesterol, low-density lipoprotein and high-density lipoprotein cholesterol and triglycerides | 2 weeks | 
| Satiety and hunger scores | Assessed using Visual Analog Scales (VAS with a scale of 1-100, where higher values correspond to stronger satiety/hunger) | 2 weeks | 
| Sleep quality and duration | Assessed by the Pittsburgh Sleep Quality Index (PSQI score, which ranges from 0-21, where higher values correspond to worse sleep quality) and also monitored by an ActiGraph device | 1-2 weeks | 
| Physical activity | 24-h physical activity will be monitored by an ActiGraph device | 7 days | 
| Expression of metabolic genes in adipose tissue | RNA-Seq analysis of subcutaneous adipose tissue samples | 2 weeks | 
| Social and economic decision behaviour | Assessed by computer tests together with the Barratt Impulsiveness Scale short version (BIS-15 with a score between 15 and 60, where higher values correspond to higher impulsiveness) and the UCLA Loneliness Scale (with a score between 20 and 100, where higher values correspond to higher subjectively perceived loneliness) | 2 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Time-restricted feeding, Meal timing, Obesity, Glycemic control, Blood lipids, Inflammation, Sleep