Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adults

Study Overview
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Brief Summary
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The present study aims to evaluate in adults with normal weight and with overweight or obesity who live in the city of La Plata the circulating levels of various hormones that regulate appetite and the gene expression of their receptors in peripheral blood mononuclear cells before and after food intake.

Detailed Description
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the investigators plan a single test meal study in males and females with normal weight (NW) or overweight/obesity (OW/OB) assessing whether plasma appetite regulatory hormones levels are associated with different metabolic and anthropometric variables as well as with appetite sensations.

Official Title
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Analysis of the Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adult Individuals

Conditions
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Obesity, Appetitive Behavior

Intervention / Treatment
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* Dietary Supplement: food (breakfast)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult individuals body mass index> 18.5 kg∙m-2 Exclusion Criteria: chronic medical illness, personal history of diabetes, history of medical condition, or medication related to obesity or diabetes risk status. Pregnancy

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Participants will be given a test meal (breakfast) that provides 20% of the individual's daily energy requirement. The breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds. Participants will be asked to consume the entire breakfast in less than 15 min and to complete a visual analog scale (VAS) questionnaire every 15 min. Blood sampling will be repeated at 60 min after starting breakfast (postprandial).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: food intake (breakfast)<br>the breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds | Dietary Supplement: food (breakfast)<br>* The breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma ghrelin concentration | ghrelin concentration (fmol/ml) | pre -prandial | 
| plasma leptin concentration | leptin concentration (ug/ml) | pre -prandial | 
| plasma glucagon-like peptide 1 concentration | glucagon-like peptide 1 concentration (ug/ml) | pre -prandial | 
| plasma liver antimicrobial peptide 2 concentration | liver antimicrobial peptide 2 concentration (pmol/ml) | pre -prandial | 
| plasma des-acyl ghrelin concentration | des-acyl ghrelin concentration (fmol/ml) | pre -prandial | 
| plasma ghrelin concentration | ghrelin concentration (fmol/ml) | 1 hour post -prandial | 
| plasma leptin concentration | leptin concentration (ug/ml) | 1 hour post -prandial | 
| plasma glucagon-like peptide 1 concentration | glucagon-like peptide 1 concentration (ug/ml) | 1 hour post -prandial | 
| plasma liver antimicrobial peptide 2 concentration | liver antimicrobial peptide 2 concentration (pmol/ml) | 1 hour post -prandial | 
| plasma des-acyl ghrelin concentration | des-acyl ghrelin concentration (fmol/ml) | 1 hour post -prandial | 
| plasma glucose concentration | glucose concentration (mg%) | pre -prandial | 
| plasma glucose concentration | glucose concentration (mg%) | 1 hour post -prandial | 
| plasma triglycerides concentration | triglycerides concentration (mg%) | pre-prandial | 
| plasma triglycerides concentration | triglycerides concentration (mg%) | 1 hour post -prandial | 
| plasma total cholesterol concentration | total cholesterol concentration (mg%) | pre -prandial | 
| plasma total cholesterol concentration | total cholesterol concentration (mg%) | 1 hour post -prandial | 
| ghrelin proteolysis | plasma proteolytic activity of ghrelin (relative units) | pre -prandial | 
| ghrelin proteolysis | plasma proteolytic activity of ghrelin (relative units) | 1 hour post -prandial | 
| ghrelin deacylation | plasma desacylase actvitity of ghrelin (relative units) | pre -prandial | 
| ghrelin deacylation | plasma desacylase actvitity of ghrelin (relative units) | 1 hour post -prandial | 
| leptin receptor gene expression in peripheral blood mononuclear cells | leptin receptor gene expression in peripheral blood mononuclear cells (relative expression) | pre-prandial | 
| insulin receptor gene expression in peripheral blood mononuclear cells | insulin receptor gene expression in peripheral blood mononuclear cells (relative expression) | pre-prandial | 
| ghrelin receptor gene expression in peripheral blood mononuclear cells | ghrelin receptor gene expression in peripheral blood mononuclear cells (relative expression) | pre-prandial | 
| hunger sensation | visual analog scale (cm) | pre-prandial and 15, 30, 45 and 60 min post-prandial | 
| fullness sensation | visual analog scale (cm) | pre-prandial and 15, 30, 45 and 60 min post-prandial | 
| desire to eat sensation | visual analog scale (cm) | pre-prandial and 15, 30, 45 and 60 min post-prandial | 
| prospective food consumption sensation | visual analog scale (cm) | pre-prandial and 15, 30, 45 and 60 min post-prandial |