ObesityNCT01692327
Study About High Fat Meal and Postprandial Lipemia
A study testing High fat meal in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
Trial summary
The hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. Read more about this study
- Who is it for?
- Ages 19 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- High fat meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2012to Jul 2014
- 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 19 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- all patients should have obesity class I (BMI between 30 and 35kg/m2);
- Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose intolerant;
- Presenting the age between 19 to 40 years.
- Waist circumference> 80 cm (IDF)
Who cannot join
- Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;
- Presence of dyslipidemia;
- smokers;
- Significant loss of body weight six months prior to the study.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Rio de Janeiro State University
Rio de Janeiro, Rio de Janeiro, 20550900
About this study
Official title: Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women
The hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. After the fat overload, we hypothesized that there will be a worsening of endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but also find lower concentrations of incretins in OB/DM2 group compared to other groups.
These hypotheses may be confirmed by techniques for evaluating microvascular function, the use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic and cardiovascular read by Multiplex kit.
Read the detailed description
Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2) treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.
Microcirculation parameters and blood tests will be assessed at baseline and after this, the women will receive a high-fat meal containing croissant, salami, whole milk and cheddar cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as well as blood collection.
- Conditions
- Obesity
- Being tested
- High fat meal
- Keywords
- glucose intolerance (20), Control (20)
- Medical subject headings
- Obesity, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High fat mealDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Obese Group | Other | Obese group with fat overload intake. Receives: Dietary Supplement: High fat meal |
| Control Group | Other | Control Group + fat overload intake Receives: Dietary Supplement: High fat meal |
| Glucose Intolerance | Other | glucose intolerance + fat overload intake Receives: Dietary Supplement: High fat meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microvascular function
Measured: up to 180 minutes after high fat meal
Secondary outcomes (1)
incretins hormones
We will assess incretins hormones by multiplex
Measured: basal, 30, 60, 120,180 minutes after high fat meal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2012
- Study completionJul 2014
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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rio de Janeiro State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priscila Alves Maranhao, Rio de Janeiro State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01692327
- Sponsor's protocol ID
- Biovasc-02
- Other IDs
- Biovasc002
- Status last verified
- Nov 2014
- First submitted
- 12 Sep 2012
- Last updated
- 5 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
de Souza MDGC, Maranhao PA, Panazzolo DG, Nogueira Neto JF, Bouskela E, Kraemer-Aguiar LG. Effects of a high-fat meal on inflammatory and endothelial injury biomarkers in accordance with adiposity status: a cross-sectional study. Nutr J. 2022 Oct 19;21(1):65. doi: 10.1186/s12937-022-00819-4.
PubMed 36258233
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effect of Lipid Overload in Endothelial Function and Microvascular Reactivity in Young Obese Women
- ClinicalTrials.gov ID
- NCT01692327
- Acronym / sponsor ID
- Biovasc-02
- Conditions
- Obesity
- Keywords
- glucose intolerance (20), Control (20)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Rio de Janeiro State UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 25 Sep 2012 (estimated)
- 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 hypothesis of the proposed project is that after a fat overload, the postprandial response is different in both groups, suggesting that the LPP will present the most significant damage in endothelial vasomotion in obese individuals, especially those with GI and T2DM. After the fat overload, we hypothesized that there will be a worsening of endothelial function and microvascular reactivity in OB/DM2 and OB group compared to C, but also find lower concentrations of incretins in OB/DM2 group compared to other groups.
These hypotheses may be confirmed by techniques for evaluating microvascular function, the use of DFT skin for vasomotion evaluation and finally analysis of analytes through metabolic and cardiovascular read by Multiplex kit.
Detailed description
Will be recruited 60 women aged 19-40 years, with a diagnosis of obesity (BMI ≥ 30 kg/m2) treated at the obesity clinic at the State University of Rio de Janeiro (UERJ)at Brazil.
Microcirculation parameters and blood tests will be assessed at baseline and after this, the women will receive a high-fat meal containing croissant, salami, whole milk and cheddar cheese. After 30, 60, 120 and 180 minutes this meal the microcirculation will be evaluated as well as blood collection.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Obese Group | Other | Dietary Supplement: High fat mealObese group with fat overload intake. |
| Control Group | Other | Dietary Supplement: High fat mealControl Group + fat overload intake |
| Glucose Intolerance | Other | Dietary Supplement: High fat mealglucose intolerance + fat overload intake |
Who may qualify
- Ages
- 19 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- all patients should have obesity class I (BMI between 30 and 35kg/m2);
- Submit diabetes mellitus without further treatment or be obese non-diabetic or glucose intolerant;
- Presenting the age between 19 to 40 years.
- Waist circumference> 80 cm (IDF)
Key exclusion criteria (4 listed)
- Renal disease, coronary or peripheral vascular, hematologic or hepatic impairment;
- Presence of dyslipidemia;
- smokers;
- Significant loss of body weight six months prior to the study.
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 |
|---|---|---|
| High fat meal | Dietary supplement | Control Group, Glucose Intolerance, Obese Group |
Primary outcome
Microvascular function
Time frame: up to 180 minutes after high fat meal
1 secondary outcome
incretins hormones
Time frame: basal, 30, 60, 120,180 minutes after high fat meal
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 5 Nov 2014.
- Derived from this study: PubMed 36258233de Souza MDGC, Maranhao PA, Panazzolo DG, Nogueira Neto JF, Bouskela E, Kraemer-Aguiar LG. Effects of a high-fat meal on inflammatory and endothelial injury biomarkers in accordance with adiposity status: a cross-sectional study. Nutr J. 2022 Oct 19;21(1):65. doi: 10.1186/s12937-022-00819-4.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High fat meal in people with Obesity, run by Rio de Janeiro State University at 1 site in Brazil.
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 4 inclusion and 4 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 5 Nov 2014. 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 Brazil. 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?
Microvascular function (time frame: up to 180 minutes after high fat meal). 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 NCT01692327, 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 5 Nov 2014; AzTrials last refreshed its copy on 30 Oct 2026.