NCT05815641

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable obesity

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 16, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
Last Updated

April 18, 2023

Status Verified

April 1, 2023

Enrollment Period

4 months

First QC Date

February 16, 2023

Last Update Submit

April 4, 2023

Conditions

ObesityAppetitive Behavior

Outcome Measures

Primary Outcomes (27)

  • 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

Study Arms (1)

food intake (breakfast)

EXPERIMENTAL

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

Dietary Supplement: food (breakfast)

Interventions

food (breakfast)DIETARY_SUPPLEMENT

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

food intake (breakfast)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • adult individuals body mass index\> 18.5 kg∙m-2

You may not qualify if:

  • chronic medical illness, personal history of diabetes, history of medical condition, or medication related to obesity or diabetes risk status.
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)

La Plata, Buenos Aires, 1900, Argentina

Location

Related Publications (1)

  • Andreoli MF, Fittipaldi AS, Castrogiovanni D, De Francesco PN, Valdivia S, Heredia F, Ribet-Travers C, Mendez I, Fasano MV, Schioth HB, Doi SA, Habib AM, Perello M. Pre-prandial plasma liver-expressed antimicrobial peptide 2 (LEAP2) concentration in humans is inversely associated with hunger sensation in a ghrelin independent manner. Eur J Nutr. 2024 Apr;63(3):751-762. doi: 10.1007/s00394-023-03304-8. Epub 2023 Dec 29.

    PMID: 38157050DERIVED

MeSH Terms

Conditions

ObesityAppetitive Behavior

Interventions

FoodBreakfast

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

Diet, Food, and NutritionPhysiological PhenomenaFood and BeveragesMeals

Study Officials

  • Maria F Andreoli

    Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2023

First Posted

April 18, 2023

Study Start

September 1, 2021

Primary Completion

December 15, 2021

Study Completion

December 15, 2021

Last Updated

April 18, 2023

Record last verified: 2023-04

Data Sharing

IPD Sharing
Will not share

Locations

AR(1)