ObesityNCT05815641
Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adults
A study testing food (breakfast) in people with Obesity and Appetitive Behavior, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 1 site in Argentina.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Appetitive Behavior
- What is being tested?
- food (breakfast)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteArgentina
- Study dates
- 1 Sep 2021to 15 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- adult individuals body mass index> 18.5 kg∙m-2
Who cannot join
- chronic medical illness, personal history of diabetes, history of medical condition, or medication related to obesity or diabetes risk status.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Argentina1 site
Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)
La Plata, Buenos Aires, 1900
About this study
Official title: Analysis of the Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adult Individuals
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.
- Conditions
- Obesity, Appetitive Behavior
- Being tested
- food (breakfast)
- Medical subject headings
- Obesity, Appetitive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
food (breakfast)Dietary supplement
The breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds
| Study group | Role | What they receive |
|---|---|---|
| food intake (breakfast) | Experimental | the breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds Receives: Dietary Supplement: food (breakfast) |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma ghrelin concentration
ghrelin concentration (fmol/ml)
Measured: pre -prandial
plasma leptin concentration
leptin concentration (ug/ml)
Measured: pre -prandial
plasma glucagon-like peptide 1 concentration
glucagon-like peptide 1 concentration (ug/ml)
Measured: pre -prandial
plasma liver antimicrobial peptide 2 concentration
liver antimicrobial peptide 2 concentration (pmol/ml)
Measured: pre -prandial
plasma des-acyl ghrelin concentration
des-acyl ghrelin concentration (fmol/ml)
Measured: pre -prandial
plasma ghrelin concentration
ghrelin concentration (fmol/ml)
Measured: 1 hour post -prandial
plasma leptin concentration
leptin concentration (ug/ml)
Measured: 1 hour post -prandial
plasma glucagon-like peptide 1 concentration
glucagon-like peptide 1 concentration (ug/ml)
Measured: 1 hour post -prandial
plasma liver antimicrobial peptide 2 concentration
liver antimicrobial peptide 2 concentration (pmol/ml)
Measured: 1 hour post -prandial
plasma des-acyl ghrelin concentration
des-acyl ghrelin concentration (fmol/ml)
Measured: 1 hour post -prandial
plasma glucose concentration
glucose concentration (mg%)
Measured: pre -prandial
plasma glucose concentration
glucose concentration (mg%)
Measured: 1 hour post -prandial
plasma triglycerides concentration
triglycerides concentration (mg%)
Measured: pre-prandial
plasma triglycerides concentration
triglycerides concentration (mg%)
Measured: 1 hour post -prandial
plasma total cholesterol concentration
total cholesterol concentration (mg%)
Measured: pre -prandial
plasma total cholesterol concentration
total cholesterol concentration (mg%)
Measured: 1 hour post -prandial
ghrelin proteolysis
plasma proteolytic activity of ghrelin (relative units)
Measured: pre -prandial
ghrelin proteolysis
plasma proteolytic activity of ghrelin (relative units)
Measured: 1 hour post -prandial
ghrelin deacylation
plasma desacylase actvitity of ghrelin (relative units)
Measured: pre -prandial
ghrelin deacylation
plasma desacylase actvitity of ghrelin (relative units)
Measured: 1 hour post -prandial
leptin receptor gene expression in peripheral blood mononuclear cells
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: pre-prandial
insulin receptor gene expression in peripheral blood mononuclear cells
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: pre-prandial
ghrelin receptor gene expression in peripheral blood mononuclear cells
ghrelin receptor gene expression in peripheral blood mononuclear cells (relative expression)
Measured: pre-prandial
hunger sensation
visual analog scale (cm)
Measured: pre-prandial and 15, 30, 45 and 60 min post-prandial
fullness sensation
visual analog scale (cm)
Measured: pre-prandial and 15, 30, 45 and 60 min post-prandial
"desire to eat" sensation
visual analog scale (cm)
Measured: pre-prandial and 15, 30, 45 and 60 min post-prandial
"prospective food consumption" sensation
visual analog scale (cm)
Measured: pre-prandial and 15, 30, 45 and 60 min post-prandial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start1 Sep 2021
- Primary completion15 Dec 2021
- Study completion15 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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).
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria F Andreoli, Principal investigator, Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815641
- Sponsor's protocol ID
- 2020/0044
- Status last verified
- Apr 2023
- First submitted
- 16 Feb 2023
- Last updated
- 18 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38157050
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of the Pre- and Post-prandial Levels of Appetite Regulatory Hormones in Adult Individuals
- ClinicalTrials.gov ID
- NCT05815641
- Acronym / sponsor ID
- 2020/0044
- Conditions
- Obesity, Appetitive Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. ViteriUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 15 Dec 2021 (actual)
- Study completion
- 15 Dec 2021 (actual)
- First posted
- 18 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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).
| Arm | Type | Receives |
|---|---|---|
| food intake (breakfast) | Experimental | Dietary Supplement: food (breakfast)the breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- adult individuals body mass index> 18.5 kg∙m-2
Key exclusion criteria (2 listed)
- chronic medical illness, personal history of diabetes, history of medical condition, or medication related to obesity or diabetes risk status.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| food (breakfast)The breakfast composition is 56 kcal% carbohydrates, 12 kcal% protein and 34 kcal% lipids and comprises yogurt, cereals and almonds | Dietary supplement | food intake (breakfast) |
Primary outcome
plasma ghrelin concentration
Time frame: pre -prandial
ghrelin concentration (fmol/ml)
plasma leptin concentration
Time frame: pre -prandial
leptin concentration (ug/ml)
plasma glucagon-like peptide 1 concentration
Time frame: pre -prandial
glucagon-like peptide 1 concentration (ug/ml)
plasma liver antimicrobial peptide 2 concentration
Time frame: pre -prandial
liver antimicrobial peptide 2 concentration (pmol/ml)
plasma des-acyl ghrelin concentration
Time frame: pre -prandial
des-acyl ghrelin concentration (fmol/ml)
plasma ghrelin concentration
Time frame: 1 hour post -prandial
ghrelin concentration (fmol/ml)
plasma leptin concentration
Time frame: 1 hour post -prandial
leptin concentration (ug/ml)
plasma glucagon-like peptide 1 concentration
Time frame: 1 hour post -prandial
glucagon-like peptide 1 concentration (ug/ml)
plasma liver antimicrobial peptide 2 concentration
Time frame: 1 hour post -prandial
liver antimicrobial peptide 2 concentration (pmol/ml)
plasma des-acyl ghrelin concentration
Time frame: 1 hour post -prandial
des-acyl ghrelin concentration (fmol/ml)
plasma glucose concentration
Time frame: pre -prandial
glucose concentration (mg%)
plasma glucose concentration
Time frame: 1 hour post -prandial
glucose concentration (mg%)
plasma triglycerides concentration
Time frame: pre-prandial
triglycerides concentration (mg%)
plasma triglycerides concentration
Time frame: 1 hour post -prandial
triglycerides concentration (mg%)
plasma total cholesterol concentration
Time frame: pre -prandial
total cholesterol concentration (mg%)
plasma total cholesterol concentration
Time frame: 1 hour post -prandial
total cholesterol concentration (mg%)
ghrelin proteolysis
Time frame: pre -prandial
plasma proteolytic activity of ghrelin (relative units)
ghrelin proteolysis
Time frame: 1 hour post -prandial
plasma proteolytic activity of ghrelin (relative units)
ghrelin deacylation
Time frame: pre -prandial
plasma desacylase actvitity of ghrelin (relative units)
ghrelin deacylation
Time frame: 1 hour post -prandial
plasma desacylase actvitity of ghrelin (relative units)
leptin receptor gene expression in peripheral blood mononuclear cells
Time frame: pre-prandial
leptin receptor gene expression in peripheral blood mononuclear cells (relative expression)
insulin receptor gene expression in peripheral blood mononuclear cells
Time frame: pre-prandial
insulin receptor gene expression in peripheral blood mononuclear cells (relative expression)
ghrelin receptor gene expression in peripheral blood mononuclear cells
Time frame: pre-prandial
ghrelin receptor gene expression in peripheral blood mononuclear cells (relative expression)
hunger sensation
Time frame: pre-prandial and 15, 30, 45 and 60 min post-prandial
visual analog scale (cm)
fullness sensation
Time frame: pre-prandial and 15, 30, 45 and 60 min post-prandial
visual analog scale (cm)
"desire to eat" sensation
Time frame: pre-prandial and 15, 30, 45 and 60 min post-prandial
visual analog scale (cm)
"prospective food consumption" sensation
Time frame: pre-prandial and 15, 30, 45 and 60 min post-prandial
visual analog scale (cm)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Derived from this study: PubMed 38157050Andreoli 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria F Andreoli principal investigator
Instituto de Desarrollo e Investigaciones Pediátricas (IDIP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing food (breakfast) in people with Obesity and Appetitive Behavior, run by Instituto de Desarrollo e Investigaciones Pediátricas Prof. Dr. Fernando E. Viteri at 1 site in Argentina.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Argentina. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma ghrelin concentration (time frame: pre -prandial). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05815641, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.