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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05815641
• Other study ID #: 2020/0044
• Status: Completed
• Phase: N/A
• Start date: September 1, 2021
• Est. completion date: December 15, 2021

Study information

• Verified date: April 2023
• Source: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 15, 2021
• Est. primary completion date: December 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Appetitive Behavior
• Obesity

Intervention

Dietary Supplement:
• food (breakfast)
The breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds

Locations

Country	Name	City	State
Argentina	Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)	La Plata	Buenos Aires

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri

Country where clinical trial is conducted

Argentina, 

Outcome

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