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CompletedNCT05815641Updated Apr 18, 2023

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

An interventional study of food (breakfast) in Obesity and Appetitive Behavior, sponsored by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri. Completed at 1 site in Argentina. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-04-18.

Sponsored by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 1 year 5 months after the study started (first participant enrolled Sep 2021, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
66
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Obesity
  • Appetitive Behavior
03

In context

Lead sponsor

Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri is the lead sponsor of 4 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Pregnancy

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
66 participants (actual)

Study arms

  • Experimental
    food intake (breakfast)

    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

  • Dietary supplementfood (breakfast)

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

06

What researchers measure

Primary outcomes

  1. plasma ghrelin concentration

    ghrelin concentration (fmol/ml)

    Time frame: pre -prandial

  2. plasma leptin concentration

    leptin concentration (ug/ml)

    Time frame: pre -prandial

  3. plasma glucagon-like peptide 1 concentration

    glucagon-like peptide 1 concentration (ug/ml)

    Time frame: pre -prandial

  4. plasma liver antimicrobial peptide 2 concentration

    liver antimicrobial peptide 2 concentration (pmol/ml)

    Time frame: pre -prandial

  5. plasma des-acyl ghrelin concentration

    des-acyl ghrelin concentration (fmol/ml)

    Time frame: pre -prandial

  6. plasma ghrelin concentration

    ghrelin concentration (fmol/ml)

    Time frame: 1 hour post -prandial

  7. plasma leptin concentration

    leptin concentration (ug/ml)

    Time frame: 1 hour post -prandial

  8. plasma glucagon-like peptide 1 concentration

    glucagon-like peptide 1 concentration (ug/ml)

    Time frame: 1 hour post -prandial

  9. plasma liver antimicrobial peptide 2 concentration

    liver antimicrobial peptide 2 concentration (pmol/ml)

    Time frame: 1 hour post -prandial

  10. plasma des-acyl ghrelin concentration

    des-acyl ghrelin concentration (fmol/ml)

    Time frame: 1 hour post -prandial

  11. plasma glucose concentration

    glucose concentration (mg%)

    Time frame: pre -prandial

  12. plasma glucose concentration

    glucose concentration (mg%)

    Time frame: 1 hour post -prandial

  13. plasma triglycerides concentration

    triglycerides concentration (mg%)

    Time frame: pre-prandial

  14. plasma triglycerides concentration

    triglycerides concentration (mg%)

    Time frame: 1 hour post -prandial

  15. plasma total cholesterol concentration

    total cholesterol concentration (mg%)

    Time frame: pre -prandial

  16. plasma total cholesterol concentration

    total cholesterol concentration (mg%)

    Time frame: 1 hour post -prandial

  17. ghrelin proteolysis

    plasma proteolytic activity of ghrelin (relative units)

    Time frame: pre -prandial

  18. ghrelin proteolysis

    plasma proteolytic activity of ghrelin (relative units)

    Time frame: 1 hour post -prandial

  19. ghrelin deacylation

    plasma desacylase actvitity of ghrelin (relative units)

    Time frame: pre -prandial

  20. ghrelin deacylation

    plasma desacylase actvitity of ghrelin (relative units)

    Time frame: 1 hour post -prandial

  21. leptin receptor gene expression in peripheral blood mononuclear cells

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

    Time frame: pre-prandial

  22. insulin receptor gene expression in peripheral blood mononuclear cells

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

    Time frame: pre-prandial

  23. ghrelin receptor gene expression in peripheral blood mononuclear cells

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

    Time frame: pre-prandial

  24. hunger sensation

    visual analog scale (cm)

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

  25. fullness sensation

    visual analog scale (cm)

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

  26. "desire to eat" sensation

    visual analog scale (cm)

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

  27. "prospective food consumption" sensation

    visual analog scale (cm)

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

07

Study locations

1 site
  • Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)
    La Plata, Buenos Aires 1900, Argentina
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05815641
Lead sponsor
Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
Responsible party
Sponsor
First posted
Apr 18, 2023
Start date
Sep 1, 2021
Primary completion
Dec 15, 2021
Completion
Dec 15, 2021
Last update
Apr 18, 2023

Study contacts

Maria F Andreoli
principal investigator · Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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