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

Not Applicable

Completed

• Conditions: Appetitive Behavior; Obesity
• Interventions: Dietary Supplement: food (breakfast)

• Registration Number: NCT05815641
• Lead Sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Brief Summary

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

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.

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2021-12-15
• Study Completion: 2021-12-15
• Study First Submitted: 2023-02-16
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-04
• Last Update Submitted: 2023-04-04
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
food intake (breakfast)	food (breakfast)	the breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds

Primary Outcome Measures

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

Trial Locations

Locations (1)

Instituto de Desarrollo e Investigaciones Pediátricas (IDIP); 🇦🇷 La Plata, Buenos Aires, Argentina