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Completed

NCT Number: NCT05815641

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

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.

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Key information

Conditions

Obesity Appetitive Behavior Behavior Behavior, Animal Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)

La Plata, Buenos Aires, 1900, Argentina

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

food (breakfast)

Dietary Supplement

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

Primary outcomes

  1. plasma ghrelin concentration

    Time frame: pre -prandial

    ghrelin concentration (fmol/ml)

  2. plasma leptin concentration

    Time frame: pre -prandial

    leptin concentration (ug/ml)

  3. plasma glucagon-like peptide 1 concentration

    Time frame: pre -prandial

    glucagon-like peptide 1 concentration (ug/ml)

  4. plasma liver antimicrobial peptide 2 concentration

    Time frame: pre -prandial

    liver antimicrobial peptide 2 concentration (pmol/ml)

  5. plasma des-acyl ghrelin concentration

    Time frame: pre -prandial

    des-acyl ghrelin concentration (fmol/ml)

  6. plasma ghrelin concentration

    Time frame: 1 hour post -prandial

    ghrelin concentration (fmol/ml)

  7. plasma leptin concentration

    Time frame: 1 hour post -prandial

    leptin concentration (ug/ml)

  8. plasma glucagon-like peptide 1 concentration

    Time frame: 1 hour post -prandial

    glucagon-like peptide 1 concentration (ug/ml)

  9. plasma liver antimicrobial peptide 2 concentration

    Time frame: 1 hour post -prandial

    liver antimicrobial peptide 2 concentration (pmol/ml)

  10. plasma des-acyl ghrelin concentration

    Time frame: 1 hour post -prandial

    des-acyl ghrelin concentration (fmol/ml)

  11. plasma glucose concentration

    Time frame: pre -prandial

    glucose concentration (mg%)

  12. plasma glucose concentration

    Time frame: 1 hour post -prandial

    glucose concentration (mg%)

  13. plasma triglycerides concentration

    Time frame: pre-prandial

    triglycerides concentration (mg%)

  14. plasma triglycerides concentration

    Time frame: 1 hour post -prandial

    triglycerides concentration (mg%)

  15. plasma total cholesterol concentration

    Time frame: pre -prandial

    total cholesterol concentration (mg%)

  16. plasma total cholesterol concentration

    Time frame: 1 hour post -prandial

    total cholesterol concentration (mg%)

  17. ghrelin proteolysis

    Time frame: pre -prandial

    plasma proteolytic activity of ghrelin (relative units)

  18. ghrelin proteolysis

    Time frame: 1 hour post -prandial

    plasma proteolytic activity of ghrelin (relative units)

  19. ghrelin deacylation

    Time frame: pre -prandial

    plasma desacylase actvitity of ghrelin (relative units)

  20. ghrelin deacylation

    Time frame: 1 hour post -prandial

    plasma desacylase actvitity of ghrelin (relative units)

  21. leptin receptor gene expression in peripheral blood mononuclear cells

    Time frame: pre-prandial

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

  22. insulin receptor gene expression in peripheral blood mononuclear cells

    Time frame: pre-prandial

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

  23. ghrelin receptor gene expression in peripheral blood mononuclear cells

    Time frame: pre-prandial

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

  24. hunger sensation

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

    visual analog scale (cm)

  25. fullness sensation

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

    visual analog scale (cm)

  26. "desire to eat" sensation

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

    visual analog scale (cm)

  27. "prospective food consumption" sensation

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

    visual analog scale (cm)

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 18, 2023
Registry last updated
Apr 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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