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

NCT ID: NCT05815641

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-01

Study Completion Date

2021-12-15

Brief Summary

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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

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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.

Conditions

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Obesity Appetitive Behavior

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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food intake (breakfast)

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

Group Type EXPERIMENTAL

food (breakfast)

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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food (breakfast)

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria F Andreoli

Role: PRINCIPAL_INVESTIGATOR

Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)

Locations

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Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)

La Plata, Buenos Aires, Argentina

Site Status

Countries

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Argentina

References

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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.

Reference Type DERIVED
PMID: 38157050 (View on PubMed)

Other Identifiers

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2020/0044

Identifier Type: -

Identifier Source: org_study_id

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