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Clinical Trials/NCT05815641
NCT05815641CompletedNot Applicable

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

Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri1 site in 1 country66 target enrollmentStarted: September 1, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
66
Locations
1
Primary Endpoint
plasma leptin concentration

Study Overview

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Prevention
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

food intake (breakfast)

Experimental

the breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds

Intervention: food (breakfast) (Dietary Supplement)

Outcomes

Primary Outcomes

plasma leptin concentration

Time Frame: 1 hour post -prandial

leptin concentration (ug/ml)

plasma glucagon-like peptide 1 concentration

Time Frame: 1 hour post -prandial

glucagon-like peptide 1 concentration (ug/ml)

plasma ghrelin concentration

Time Frame: 1 hour post -prandial

ghrelin concentration (fmol/ml)

plasma des-acyl ghrelin concentration

Time Frame: 1 hour post -prandial

des-acyl ghrelin concentration (fmol/ml)

ghrelin deacylation

Time Frame: 1 hour post -prandial

plasma desacylase actvitity of ghrelin (relative units)

hunger sensation

Time Frame: pre-prandial and 15, 30, 45 and 60 min post-prandial

visual analog scale (cm)

plasma liver antimicrobial peptide 2 concentration

Time Frame: 1 hour post -prandial

liver antimicrobial peptide 2 concentration (pmol/ml)

plasma glucose concentration

Time Frame: 1 hour post -prandial

glucose concentration (mg%)

insulin receptor gene expression in peripheral blood mononuclear cells

Time Frame: pre-prandial

insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)

"prospective food consumption" sensation

Time Frame: pre-prandial and 15, 30, 45 and 60 min post-prandial

visual analog scale (cm)

plasma triglycerides concentration

Time Frame: 1 hour post -prandial

triglycerides concentration (mg%)

leptin receptor gene expression in peripheral blood mononuclear cells

Time Frame: pre-prandial

leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)

ghrelin receptor gene expression in peripheral blood mononuclear cells

Time Frame: pre-prandial

ghrelin receptor gene expression in peripheral blood mononuclear cells (relative expression)

plasma total cholesterol concentration

Time Frame: 1 hour post -prandial

total cholesterol concentration (mg%)

ghrelin proteolysis

Time Frame: 1 hour post -prandial

plasma proteolytic activity of ghrelin (relative units)

fullness sensation

Time Frame: pre-prandial and 15, 30, 45 and 60 min post-prandial

visual analog scale (cm)

"desire to eat" sensation

Time Frame: pre-prandial and 15, 30, 45 and 60 min post-prandial

visual analog scale (cm)

plasma ghrelin concentration

Time Frame: pre -prandial

ghrelin concentration (fmol/ml)

plasma leptin concentration

Time Frame: pre -prandial

leptin concentration (ug/ml)

plasma glucagon-like peptide 1 concentration

Time Frame: pre -prandial

glucagon-like peptide 1 concentration (ug/ml)

plasma liver antimicrobial peptide 2 concentration

Time Frame: pre -prandial

liver antimicrobial peptide 2 concentration (pmol/ml)

plasma des-acyl ghrelin concentration

Time Frame: pre -prandial

des-acyl ghrelin concentration (fmol/ml)

plasma glucose concentration

Time Frame: pre -prandial

glucose concentration (mg%)

plasma triglycerides concentration

Time Frame: pre-prandial

triglycerides concentration (mg%)

plasma total cholesterol concentration

Time Frame: pre -prandial

total cholesterol concentration (mg%)

ghrelin proteolysis

Time Frame: pre -prandial

plasma proteolytic activity of ghrelin (relative units)

ghrelin deacylation

Time Frame: pre -prandial

plasma desacylase actvitity of ghrelin (relative units)

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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