ObesityNCT02079116
Ingestion of Lipids and Changes in Cerebral Blood Flow of People With Obesity
A study testing 60 grams of fat plus water solution and Pure water in people with Obesity, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
This study aims to determine changes in cerebral blood flow of people with obesity after the ingestion of fat. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- 60 grams of fat plus water solution and Pure water
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2012to Apr 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 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Live in Ribeirão Preto, São Paulo - Brazil.
- Regular menses.
- Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity.
- BMI between 18,5 and 24,9 kg/m2, for the group without obesity.
Who cannot join
- High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease.
- Psychiatric disorders, alcoholism, smoking or illicit drug abuse.
- Pregnancy or desire to be pregnant
- Use of medications, excluding contraceptives.
- Contraindication for magnetic resonance imaging.
- Be in treatment for obesity.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital of Ribeirao Preto
Ribeirão Preto, São Paulo, 14048-900
About this study
Official title: Acute Ingestion of Lipids and Alteration of Cerebral Perfusion in Obese Patients.
This study aims to determine changes in cerebral blood flow of people with obesity after the ingestion of fat.
- Conditions
- Obesity
- Being tested
- 60 grams of fat plus water solution, Pure water
- Keywords
- Obesity, Lipids, Single Photon Emission Computed Tomography, Functional Neuroimaging
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
60 grams of fat plus water solutionOther
A solution composed by 60 grams of fat and water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
- 300 mL final volume of the solution.
- Time of oral ingestion inferior than 2 minutes.
- 60 minutes before the radiopharmaceutical injection.
- 12 hours fasting minimum.
Pure waterOther
Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
- 300 mL final volume of the solution.
- Time of oral ingestion inferior than 2 minutes.
- 30 minutes before the radiopharmaceutical injection.
- 12 hours fasting minimum.
| Study group | Role | What they receive |
|---|---|---|
| 60 grams of fat plus water solution | Experimental | In the group with 10 volunteers with obesity, some of them are submitted first to the 60 grams of fat plus water solution (meal challenge) and in another time to only water.
Also, in the group with 10 volunteers without obesity, some of them are submitted first to the 60 grams of fat plus water solution (meal challenge) and in another time to only water. Receives: Other: 60 grams of fat plus water solution; Other: Pure water |
| Pure water. | Placebo comparator | In the same group with 10 volunteers with obesity, some of them are submitted first to only water (control) and in another time to the 60 grams of fat plus water solution (meal challenge).
Also, in the same group with 10 volunteers without obesity, some of them are submitted first to only water (control) and in another time to the 60 grams of fat plus water solution (meal challenge). Receives: Other: 60 grams of fat plus water solution; Other: Pure water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping.
Using 99m technetium ecd radiopharmaceutical, this study aims to detect rCBF differences between SPECT images performed after a meal challenge composed by 60 grams of fat and water and also after a challenge constituted by only water (control), both ingested orally. This approach is performed in a group of 10 people with obesity and also in 10 people without obesity.
Measured: 60 minutes after a meal challenge (time of radiopharmaceutical injection)
Secondary outcomes (2)
Blood levels mean differences within both groups, with and without obesity and across these groups, of hormones and metabolites by multiplexed assay using luminex technology and spectrophotometry, respectively.
This study looks for mean differences of blood levels within and across groups with and without obesity. The metabolites and hormones/cytokines measured are, respectively: glucose and triacylglycerols (measured by spectrophotometry), insulin, leptin, amylin, interleukin 6 (IL-6), tumor necrosis factor alpha, active ghrelin, peptide yy (PYY) and pancreatic polypeptide (PP) (multiplexed assay using luminex).
Measured: 60 and 30 minutes before, at the time and 30 and 60 minutes after the radiopharmaceutical injection.
Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.
This study also aims to measure and compare the REE by indirect calorimetry with a Quark (Cosmed, Italy) calorimeter and the body composition by Byodinamics 450 (Biodynamics Corp., United States) within the two groups and across them.
Measured: 6 hours before SPECT acquisition.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2014 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Principal investigator, Julio Sergio Marchini, University of Sao Paulo
- Investigators
- Júlio S Marchini, Ph.D, Principal investigator, Ribeirão Preto Medical School. São Paulo University (USP)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02079116
- Sponsor's protocol ID
- Process HCRP: 14080/2011
- Other IDs
- CAAE - 0335.0.004.000-11
- Status last verified
- May 2014
- First submitted
- 1 Mar 2014
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Tataranni PA, DelParigi A. Functional neuroimaging: a new generation of human brain studies in obesity research. Obes Rev. 2003 Nov;4(4):229-38. doi: 10.1046/j.1467-789x.2003.00111.x.
PubMed 14649373Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.
PubMed 15380917Lambert JE, Parks EJ. Postprandial metabolism of meal triglyceride in humans. Biochim Biophys Acta. 2012 May;1821(5):721-6. doi: 10.1016/j.bbalip.2012.01.006. Epub 2012 Jan 17.
PubMed 22281699Lairon D, Lopez-Miranda J, Williams C. Methodology for studying postprandial lipid metabolism. Eur J Clin Nutr. 2007 Oct;61(10):1145-61. doi: 10.1038/sj.ejcn.1602749. Epub 2007 Apr 25.
PubMed 17457341Goldstone AP. The hypothalamus, hormones, and hunger: alterations in human obesity and illness. Prog Brain Res. 2006;153:57-73. doi: 10.1016/S0079-6123(06)53003-1.
PubMed 16876568Figlewicz DP, Benoit SC. Insulin, leptin, and food reward: update 2008. Am J Physiol Regul Integr Comp Physiol. 2009 Jan;296(1):R9-R19. doi: 10.1152/ajpregu.90725.2008. Epub 2008 Oct 22.
PubMed 18945945Kishi T, Elmquist JK. Body weight is regulated by the brain: a link between feeding and emotion. Mol Psychiatry. 2005 Feb;10(2):132-46. doi: 10.1038/sj.mp.4001638.
PubMed 15630408DelParigi A, Chen K, Salbe AD, Reiman EM, Tataranni PA. Sensory experience of food and obesity: a positron emission tomography study of the brain regions affected by tasting a liquid meal after a prolonged fast. Neuroimage. 2005 Jan 15;24(2):436-43. doi: 10.1016/j.neuroimage.2004.08.035.
PubMed 15627585Suen VM, Silva GA, Tannus AF, Unamuno MR, Marchini JS. Effect of hypocaloric meals with different macronutrient compositions on energy metabolism and lung function in obese women. Nutrition. 2003 Sep;19(9):703-7. doi: 10.1016/s0899-9007(03)00104-7.
PubMed 12921877Wichert-Ana L, Velasco TR, Terra-Bustamante VC, Araujo D Jr, Junior VA, Kato M, Leite JP, Assirati JA, MacHado HR, Bastos AC, Sakamoto AC. Typical and atypical perfusion patterns in periictal SPECT of patients with unilateral temporal lobe epilepsy. Epilepsia. 2001 May;42(5):660-6. doi: 10.1046/j.1528-1157.2001.41900.x.
PubMed 11380575
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Ingestion of Lipids and Alteration of Cerebral Perfusion in Obese Patients.
- ClinicalTrials.gov ID
- NCT02079116
- Acronym / sponsor ID
- Process HCRP: 14080/2011
- Conditions
- Obesity
- Keywords
- Obesity, Lipids, Single Photon Emission Computed Tomography, Functional Neuroimaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 5 Mar 2014 (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.
This study aims to determine changes in cerebral blood flow of people with obesity after the ingestion of fat.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 60 grams of fat plus water solution | Experimental | Other: 60 grams of fat plus water solution, Other: Pure waterIn the group with 10 volunteers with obesity, some of them are submitted first to the 60 grams of fat plus water solution (meal challenge) and in another time to only water. Also, in the group with 10 volunteers without obesity, some of them are submitted first to the 60 grams of fat plus water solution (meal challenge) and in another time to only water. |
| Pure water. | Placebo comparator | Other: 60 grams of fat plus water solution, Other: Pure waterIn the same group with 10 volunteers with obesity, some of them are submitted first to only water (control) and in another time to the 60 grams of fat plus water solution (meal challenge). Also, in the same group with 10 volunteers without obesity, some of them are submitted first to only water (control) and in another time to the 60 grams of fat plus water solution (meal challenge). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Live in Ribeirão Preto, São Paulo - Brazil.
- Regular menses.
- Weight inferior than 120 Kg and body mass index (BMI) between 30 and 40 kg/m2, for the group with obesity.
- BMI between 18,5 and 24,9 kg/m2, for the group without obesity.
Key exclusion criteria (6 listed)
- High blood pressure, diabetes, glucose intolerance or impaired fasting glycemia, metabolic syndrome, hypothyroidism and any kidney, liver, heart or neurologic disease.
- Psychiatric disorders, alcoholism, smoking or illicit drug abuse.
- Pregnancy or desire to be pregnant
- Use of medications, excluding contraceptives.
- Contraindication for magnetic resonance imaging.
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 |
|---|---|---|
| 60 grams of fat plus water solutionA solution composed by 60 grams of fat and water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow: * 300 mL final volume of the solution. * Time of oral ingestion inferior than 2 minutes. * 60 minutes before the radiopharmaceutical injection. * 12 hours fasting minimum. | Other | 60 grams of fat plus water solution, Pure water. |
| Pure waterPure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow: * 300 mL final volume of the solution. * Time of oral ingestion inferior than 2 minutes. * 30 minutes before the radiopharmaceutical injection. * 12 hours fasting minimum. | Other | 60 grams of fat plus water solution, Pure water. |
Primary outcome
Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping.
Time frame: 60 minutes after a meal challenge (time of radiopharmaceutical injection)
Using 99m technetium ecd radiopharmaceutical, this study aims to detect rCBF differences between SPECT images performed after a meal challenge composed by 60 grams of fat and water and also after a challenge constituted by only water (control), both ingested orally. This approach is performed in a group of 10 people with obesity and also in 10 people without obesity.
2 secondary outcomes
Blood levels mean differences within both groups, with and without obesity and across these groups, of hormones and metabolites by multiplexed assay using luminex technology and spectrophotometry, respectively.
Time frame: 60 and 30 minutes before, at the time and 30 and 60 minutes after the radiopharmaceutical injection.
Resting energy expenditure (REE) and body composition measurements by indirect calorimetry and electrical bioimpedance, respectively.
Time frame: 6 hours before SPECT acquisition.
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 14 May 2014.
- Background: PubMed 14649373Tataranni PA, DelParigi A. Functional neuroimaging: a new generation of human brain studies in obesity research. Obes Rev. 2003 Nov;4(4):229-38. doi: 10.1046/j.1467-789x.2003.00111.x.
- Background: PubMed 15380917Kyle UG, Bosaeus I, De Lorenzo AD, Deurenberg P, Elia M, Gomez JM, Heitmann BL, Kent-Smith L, Melchior JC, Pirlich M, Scharfetter H, Schols AM, Pichard C; Composition of the ESPEN Working Group. Bioelectrical impedance analysis--part I: review of principles and methods. Clin Nutr. 2004 Oct;23(5):1226-43. doi: 10.1016/j.clnu.2004.06.004.
- Background: PubMed 22281699Lambert JE, Parks EJ. Postprandial metabolism of meal triglyceride in humans. Biochim Biophys Acta. 2012 May;1821(5):721-6. doi: 10.1016/j.bbalip.2012.01.006. Epub 2012 Jan 17.
- Background: PubMed 17457341Lairon D, Lopez-Miranda J, Williams C. Methodology for studying postprandial lipid metabolism. Eur J Clin Nutr. 2007 Oct;61(10):1145-61. doi: 10.1038/sj.ejcn.1602749. Epub 2007 Apr 25.
- Background: PubMed 16876568Goldstone AP. The hypothalamus, hormones, and hunger: alterations in human obesity and illness. Prog Brain Res. 2006;153:57-73. doi: 10.1016/S0079-6123(06)53003-1.
- Background: PubMed 18945945Figlewicz DP, Benoit SC. Insulin, leptin, and food reward: update 2008. Am J Physiol Regul Integr Comp Physiol. 2009 Jan;296(1):R9-R19. doi: 10.1152/ajpregu.90725.2008. Epub 2008 Oct 22.
- Background: PubMed 15630408Kishi T, Elmquist JK. Body weight is regulated by the brain: a link between feeding and emotion. Mol Psychiatry. 2005 Feb;10(2):132-46. doi: 10.1038/sj.mp.4001638.
- Background: PubMed 15627585DelParigi A, Chen K, Salbe AD, Reiman EM, Tataranni PA. Sensory experience of food and obesity: a positron emission tomography study of the brain regions affected by tasting a liquid meal after a prolonged fast. Neuroimage. 2005 Jan 15;24(2):436-43. doi: 10.1016/j.neuroimage.2004.08.035.
- Background: PubMed 12921877Suen VM, Silva GA, Tannus AF, Unamuno MR, Marchini JS. Effect of hypocaloric meals with different macronutrient compositions on energy metabolism and lung function in obese women. Nutrition. 2003 Sep;19(9):703-7. doi: 10.1016/s0899-9007(03)00104-7.
- Background: PubMed 11380575Wichert-Ana L, Velasco TR, Terra-Bustamante VC, Araujo D Jr, Junior VA, Kato M, Leite JP, Assirati JA, MacHado HR, Bastos AC, Sakamoto AC. Typical and atypical perfusion patterns in periictal SPECT of patients with unilateral temporal lobe epilepsy. Epilepsia. 2001 May;42(5):660-6. doi: 10.1046/j.1528-1157.2001.41900.x.
- Record in the National Committee of Ethics in ResearchLink provided by the sponsor.
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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.
Júlio S Marchini, Ph.D principal investigator
Ribeirão Preto Medical School. São Paulo University (USP)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 60 grams of fat plus water solution and Pure water in people with Obesity, run by University of Sao Paulo 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 6 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 14 May 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. Some participants in this study may receive a placebo. 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?
Regional cerebral blood flow (rCBF) changes after a meal challenge, measured by Single Single-photon emission computed tomography (SPECT) and statistical parametric mapping. (time frame: 60 minutes after a meal challenge (time of radiopharmaceutical injection)). 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 NCT02079116, which also lists 10 linked publications.
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 14 May 2014.