Early Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity

Study Overview
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Brief Summary
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The aim of this study is to investigate the effect of overnight fasting versus a diurnal fasting (during daily life activities) in females with and without obesity on inflammation, neurotrophins, energy metabolism, mood, food cravings, and appetite sensations. This study will be an acute fasting intervention.

Official Title
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A Single Arm Trial Investigating the Acute Effect of Fasting on Metabolic, Inflammatory, and Behavioral Responses in Females With and Without Obesity

Conditions
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Healthy, Obese

Intervention / Treatment
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* Other: Acute Fasting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Body mass index between 18.5 and 24.9 kg/m² or equal or greater 35 kg/m²; Able to sign the informed consent. Exclusion Criteria: Chronic health conditions (e.g., cancer, renal, heart or liver disorders, and autoimmune diseases), or history of thyroid alterations or use of related medications; Use of corticosteroids, immunosuppressors, anti-inflammatories, hypoglycemics, medications for weight loss, or any medication known to interfere with metabolic and inflammatory processes (e.g., corticosteroids, nonsteroidal anti-inflammatory drugs); Previous surgery for weight loss; Inability to eat any of the components of the standardized breakfast Pregnancy or breastfeeding; Smokingç Alcohol use (>2 doses/day).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acute fasting<br>Participants will fast overnight for 10 hours (resting period), consume a santdardized breakfast, and fast during daily activities (active period) for another 10 hours. | Other: Acute Fasting<br>* The volunteers will fast overnight (10 hours) and breakfast will be offered (bread, butter, ham and industrialized fruit juice). The participants will fast for another 10 hours during daily activities.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interleukin 6 | Changes in blood interleukin-6 will be assessed at baseline and after 10 hours of fasting during daily activities | At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period ( 12 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resting energy expenditure | Changes in resting energy expenditure will be assessed at baseline and after 10 hours of fasting during daily activities using indirect calorimetry | At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period ( 12 hours) | 
| Lipid panel | Changes in lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides) will be assessed at baseline and after 10 hours of fasting during daily activities | At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period ( 12 hours) | 
| Free fatty acids | Changes in free fatty acids will be assessed at baseline and after 10 hours of fasting during daily activities | At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period ( 12 hours) | 
| Blood glucose | Changes in blood glucose will be assessed at baseline and after 10 hours of fasting during daily activities | At baseline (after overnight fasting) and end (after 10 hours of fasting during the day) of the intervention period ( 12 hours) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute fasting, Inflammatory response, Energy Expenditure