Clinical trial NCT05815641: Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adults
Official title: Analysis of the Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adult Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Appetitive Behavior
Lead sponsor: Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: plasma ghrelin concentration
timeFrame: pre -prandial
measure: plasma leptin concentration
timeFrame: pre -prandial
measure: plasma glucagon-like peptide 1 concentration
timeFrame: pre -prandial
measure: plasma liver antimicrobial peptide 2 concentration
timeFrame: pre -prandial
measure: plasma des-acyl ghrelin concentration
timeFrame: pre -prandial
measure: plasma ghrelin concentration
timeFrame: 1 hour post -prandial
measure: plasma leptin concentration
timeFrame: 1 hour post -prandial
measure: plasma glucagon-like peptide 1 concentration
timeFrame: 1 hour post -prandial
measure: plasma liver antimicrobial peptide 2 concentration
timeFrame: 1 hour post -prandial
measure: plasma des-acyl ghrelin concentration
timeFrame: 1 hour post -prandial
measure: plasma glucose concentration
timeFrame: pre -prandial
measure: plasma glucose concentration
timeFrame: 1 hour post -prandial
measure: plasma triglycerides concentration
timeFrame: pre-prandial
measure: plasma triglycerides concentration
timeFrame: 1 hour post -prandial
measure: plasma total cholesterol concentration
timeFrame: pre -prandial
measure: plasma total cholesterol concentration
timeFrame: 1 hour post -prandial
measure: ghrelin proteolysis
timeFrame: pre -prandial
measure: ghrelin proteolysis
timeFrame: 1 hour post -prandial
measure: ghrelin deacylation
timeFrame: pre -prandial
measure: ghrelin deacylation
timeFrame: 1 hour post -prandial
measure: leptin receptor gene expression in peripheral blood mononuclear cells
timeFrame: pre-prandial
measure: insulin receptor gene expression in peripheral blood mononuclear cells
timeFrame: pre-prandial
measure: ghrelin receptor gene expression in peripheral blood mononuclear cells
timeFrame: pre-prandial
measure: hunger sensation
timeFrame: pre-prandial and 15, 30, 45 and 60 min post-prandial
measure: fullness sensation
timeFrame: pre-prandial and 15, 30, 45 and 60 min post-prandial
measure: "desire to eat" sensation
timeFrame: pre-prandial and 15, 30, 45 and 60 min post-prandial
measure: "prospective food consumption" sensation
timeFrame: pre-prandial and 15, 30, 45 and 60 min post-prandial
Secondary outcomes:
Other outcomes:
Locations:
city: La Plata
country: Argentina
facility: Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)
state: Buenos Aires
Study officials:
affiliation: Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)
name: Maria F Andreoli
role: PRINCIPAL_INVESTIGATOR
References: