ObeseNCT03024359
Monounsaturated Fatty Acids and Brown/Beige Adipose Tissue in Humans
A study testing Extra virgin olive oil in people with Obese, run by University of Campinas, Brazil at 1 site in Brazil.
Trial summary
Considering the high prevalence of obesity its comorbidities in Brazil and in the world, different therapeutic measures have been suggested. It is currently known that brown/beige adipose tissue plays an important role in body weight control and there is strong evidence that its activity is inversely associated with… Read more about this study
- Who is it for?
- Ages 25 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Obese
- What is being tested?
- Extra virgin olive oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2017to Jul 2020
- 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 25 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Living outside of São Paulo;
- pregnant women;
- patients with severe or non-stabilized neurological or psychiatric problems;
- use of anti-obesity or lipid-lowering medication;
- use of adrenergic or benzodiazepine drugs;
- individuals with neoplasms, transmissible and rheumatic diseases, hepatic or renal insufficiency, untreated thyroid dysfunction; Diabetes mellitus;
- individuals that changed more than 5% of body weight in the last six months; 8) to be carrying out some kind of diet or modification in the usual dietary pattern; 9) having metal prostheses.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Ciências Médicas Unicamp
Campinas, São Paulo, 13083-887
About this study
Official title: Effect of Monounsaturated Fatty Acids Consumption in Brown/Beige Adipose Tissue Activity in Human Adults
Considering the high prevalence of obesity its comorbidities in Brazil and in the world, different therapeutic measures have been suggested. It is currently known that brown/beige adipose tissue plays an important role in body weight control and there is strong evidence that its activity is inversely associated with obesity and metabolic diseases. Recent studies have shown an important role foods and nutrients in the activation of brown/beige adipose tissue, almost exclusively in animal models. The benefits of monounsaturated fatty acids to metabolism have been described in several studies, however, the effects of consuming large amounts of olive oil in the activity of brown/beige adipose tissue in humans have not been explored. The aim of the study is to evaluate the impact of the consumption of large amounts of extra virgin olive oil in the activity of brown/beige adipose tissue in lean and obese humans. This will be a clinical trial with a total duration of 4 weeks. Obese and controls (normal weight) participants will undergo a dietary intervention for 4 weeks with extra virgin olive oil. Before and after the intervention period several data will be collected: dietary intake and physical activity data, evaluation of brown/beige adipose tissue (with 18F-fluorodeoxyglucose positron emission tomography and magnetic resonance imaging - PET/RMI), assessment of body composition (DXA), lipid profile and inflammatory markers as well as hypothalamic inflammation (functional magnetic resonance imaging) and brown adipose tissue biopsies in a subsample of 20 participants. The data will be expressed as mean and standard deviation and the variables compared by the Student t test or ANOVA for repeated measures.
Read the detailed description
- HYPOTHESIS The effects of fatty acids consumption on brown / beige adipose tissue have not yet been explored in humans. However, studies that evaluated the effects of saturated fatty acid replacement by monounsaturated fatty acids (MUFAs) or polyunsaturated fatty acids (PUFAs) on animal and human models have observed an improvement in cardiovascular risk factors, such as reduction of subclinical inflammation, improvement of lipid profile and increase in insulin sensitivity. The mechanisms by which these fatty acids act in the improvement of risk factors have not been completely clarified and it is possible that there is an association between the reduction of cardiovascular risk factors and the activation of brown / beige adipose tissue. Our hypothesis is that consuming extra virgin olive oil in high amounts for one month will promote increased brown adipose tissue (BAT) activity of the participants and improve the cardiovascular risk profile, as assessed by inflammatory markers. It is possible that the response of lean and obese subjects to dietary intervention is different and that the behavior of BAT is not equal in both groups.
- OBJECTIVE To evaluate the impact of the consumption of large amounts of extra virgin olive oil (source of monounsaturated fatty acids) on the activity of brown / beige adipose tissue in lean and obese humans. 2.1 Specific objectives • To investigate the activity of brown and beige adipose tissue by FDG PET / RMI, before and after four weeks of intervention with high amount of extra virgin olive oil; • To evaluate the expression of BAT activity markers: uncoupling protein 1 (UCP-1), PR domain containing 16 (PRDM16), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α), iodothyronine deiodinase 2 (Dio2) in mononuclear cells in the whole sample;
- To evaluate levels of fatty acids in the blood by gas chromatography, before and after the intervention to evaluate changes in fatty acid intake;
- To evaluate concentrations of pro and anti-inflammatory cytokines in the blood before and after 4 weeks of intervention: tumor necrosis factor alpha (TNF-α), interleukin 1-beta (IL1β), Monocyte Chemoattractant Protein-1 (MCP-1), interleukin-6 and interleukin-10);
- To evaluate the effects of interventions on metabolic markers before and after the intervention: leptin, insulin, glucose, total cholesterol and fractions, triglycerides;
- To evaluate the effects of the intervention on anthropometry (weight, abdominal circumference) and on the body composition evaluated by Dual-energy X-ray absorptiometry (DXA);
- To evaluate the effects of dietary interventions on brain activity (by PET/MRi) in a subsample of 15 individuals.
- MATERIALS AND METHODS This will be an open clinical trial lasting for four weeks. The study consists of two data collections before and after a 4-week dietary intervention in which participants will be required to consume extra-virgin olive oil provided by the researchers. The collection of socio demographic, dietary and physical activity data, as well as the PET / MRI and the blood collections of 50 participants will be carried out at the Nuclear Medicine Center of the Medical School of the University of São Paulo. Bone densitometry (DXA) will be performed at the School of Public Health of the University of São Paulo. Selection of participants: The estimated number of individuals with a detectable brown adipose tissue (50) is 50%, with the proportion of individuals with detectable brown adipose tissue. It will include 15 obese individuals (degree I obesity) and 35 control subjects (normal weight individuals). Participants will be selected through print and electronic media.
- Inclusion criteria For the group with obesity: Both genders, age between 25 and 40 years, BMI ≥ 30 and <35 kg / m2. For the normal weight group (control): Both genders, age between 25 and 40 years, BMI <25 kg / m2.
- Exclusion Criteria
- Residing outside of São Paulo / Campinas; 2) pregnant women; 3) patients with severe or non-stabilized neurological or psychiatric problems; 4) use of anti-obesity or lipid-lowering medication; 5) use of adrenergic or benzodiazepine drugs; 6) individuals with neoplasms, transmissible and rheumatic diseases, hepatic or renal insufficiency, untreated thyroid dysfunction; Diabetes mellitus; 7) change of more than 5% of body weight in the last six months; 8) to be carrying out some kind of diet or modification in the usual dietary pattern; 9) have metal prostheses.
- Design This is an open clinical trial with a total duration of four weeks. Obese and controls participants will be enrolled into a dietary intervention for 4 weeks with extra virgin olive oil (MUFA rich). Extra-virgin olive oil (2 liters) is provided to participants and the researchers adivice the participants to use the oil in all preparations during the four weeks. Before and after each intervention period the following data will be collected:
- Food consumption: 24-hour recall (before and after dietary intervention) and 3-day food diary;
- Physical activity data: International Physical Activity Questionnaire (IPAQ);
- Evaluation of brown / beige adipose tissue volume and activity: Positron emission tomography with fluoride-18-labeled fluorodeoxyglucose (18F-FDG) in combination with magnetic resonance (PET / MRi). For the FDG PET / RMI the participants will be allocated in a room with controlled temperature (19 degrees), with light clothes and a cooling vest for 2 hours.
- Body composition assessment: Weight (digital scale) and height (fixed stadiometer);; abdominal circumference; body composition: by Dual-energy X-ray absorptiometry (DXA);
- Biochemical dosages: plasma glucose, triglycerides, total cholesterol and HDL-c will be determined routinely and inflammatory markers will be determined by enzyme-linked immunosorbent assay (ELISA);
- Expression of UCP-1, PGC-1α, PRDM16 and Dio2 will be performed by Real-Time Polymerase chain reaction (RT-PCR);
- Composition of fatty acids in plasma will be determined by gas chromatography;
- Brain activity: will be performed in a subsample of 15 individuals using 18F-FDG PET/MRi.
- Statistical analysis Data will be expressed as mean and standard deviation and the variables compared by Student's t-test or ANOVA for repeated measures.
- Conditions
- Obese
- Being tested
- Extra virgin olive oil
- Keywords
- Obesity, Brown adipose tissue, Monounsaturated fatty acids, Hypothalamic inflammation
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extra virgin olive oilDietary supplement
2 liters of extra virgin olive oil will be given to participants to include/use in their daily foods.
| Study group | Role | What they receive |
|---|---|---|
| obese individuals | Active comparator | Individuals with BMI between 30 and 35 kg/m2 will be included in this group and will receive 4 weeks of extra virgin olive oil. Before and after the intervention period data regarding dietary intake and physical activity, brown/beige adipose tissue activity, body composition (DXA), lipid profile and inflammatory markers and brain activity (18F-FDG PET/MRI; in a subsample of 5 obese individuals)will be collected. Receives: Dietary Supplement: Extra virgin olive oil |
| normal weight individuals | Active comparator | Individuals with BMI between 18.5 and 24.99 kg/m2 will be included in this group and will receive 4 weeks of extra virgin olive oil. Before and after the intervention period data regarding dietary intake and physical activity, brown/beige adipose tissue activity, body composition (DXA), lipid profile and inflammatory markers and and brain activity (18F-FDG PET/MRI; in a subsample of 10 normal weight individuals) will be collected. Receives: Dietary Supplement: Extra virgin olive oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brown adipose tissue activity measured by increase in mean standardized disposal value (SUV)
We will investigate whether 4 weeks of olive oil consumption can increase the activity of brown adipose tissue measured by mean standardized disposal value (volume) using magnetic resonance imaging
Measured: Four weeks
Secondary outcomes (3)
Hypothalamic inflammation
To see whether the consumption of 4 weeks of olive oil is able to reduce hypothalamic inflammation in lean and obese individuals as measured by functional resonance imaging
Measured: Four weeks
Lipid profile
To see whether the consumption of 4 weeks of olive oil is able to reduce LDL and total cholesterol, as well as triglycerides concentrations
Measured: Four weeks
Inflammatory markers
To see whether the consumption of 4 weeks of olive oil is able to reduce pro-inflammatory markers (TNF-alpha, interleukin-1beta) and increase interleukin-10
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2019
- Study completionJul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ObeseStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- All subjects receive a dietary intervention with olive oil.
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo
- Responsible party
- Principal investigator, Milena Monfort Pires, University of Campinas, Brazil
- Investigators
- Milena Monfort-Pires, PhD, Principal investigator, University of CampinasLicio A Velloso, Professor, Study director, University of Campinas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03024359
- Sponsor's protocol ID
- CAAE: 60698716.1.0000.5404
- Status last verified
- Nov 2020
- First submitted
- 11 Jan 2017
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.
PubMed 19357405Vijgen GH, Bouvy ND, Teule GJ, Brans B, Hoeks J, Schrauwen P, van Marken Lichtenbelt WD. Increase in brown adipose tissue activity after weight loss in morbidly obese subjects. J Clin Endocrinol Metab. 2012 Jul;97(7):E1229-33. doi: 10.1210/jc.2012-1289. Epub 2012 Apr 24.
PubMed 22535970Chondronikola M, Annamalai P, Chao T, Porter C, Saraf MK, Cesani F, Sidossis LS. A percutaneous needle biopsy technique for sampling the supraclavicular brown adipose tissue depot of humans. Int J Obes (Lond). 2015 Oct;39(10):1561-4. doi: 10.1038/ijo.2015.76. Epub 2015 Apr 29.
PubMed 25920777Monfort-Pires M, U-Din M, Nogueira GA, de Almeida-Faria J, Sidarta-Oliveira D, Sant'Ana MR, De Lima-Junior JC, Cintra DE, de Souza HP, Ferreira SRG, Sapienza MT, Virtanen KA, Velloso LA. Short Dietary Intervention with Olive Oil Increases Brown Adipose Tissue Activity in Lean but not Overweight Subjects. J Clin Endocrinol Metab. 2021 Jan 23;106(2):472-484. doi: 10.1210/clinem/dgaa824.
PubMed 33180910
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Monounsaturated Fatty Acids Consumption in Brown/Beige Adipose Tissue Activity in Human Adults
- ClinicalTrials.gov ID
- NCT03024359
- Acronym / sponsor ID
- CAAE: 60698716.1.0000.5404
- Conditions
- Obese
- Keywords
- Obesity, Brown adipose tissue, Monounsaturated fatty acids, Hypothalamic inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- University of Sao Paulo
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jul 2020 (actual)
- First posted
- 18 Jan 2017 (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.
Considering the high prevalence of obesity its comorbidities in Brazil and in the world, different therapeutic measures have been suggested. It is currently known that brown/beige adipose tissue plays an important role in body weight control and there is strong evidence that its activity is inversely associated with obesity and metabolic diseases. Recent studies have shown an important role foods and nutrients in the activation of brown/beige adipose tissue, almost exclusively in animal models. The benefits of monounsaturated fatty acids to metabolism have been described in several studies, however, the effects of consuming large amounts of olive oil in the activity of brown/beige adipose tissue in humans have not been explored. The aim of the study is to evaluate the impact of the consumption of large amounts of extra virgin olive oil in the activity of brown/beige adipose tissue in lean and obese humans. This will be a clinical trial with a total duration of 4 weeks. Obese and controls (normal weight) participants will undergo a dietary intervention for 4 weeks with extra virgin olive oil. Before and after the intervention period several data will be collected: dietary intake and physical activity data, evaluation of brown/beige adipose tissue (with 18F-fluorodeoxyglucose positron emission tomography and magnetic resonance imaging - PET/RMI), assessment of body composition (DXA), lipid profile and inflammatory markers as well as hypothalamic inflammation (functional magnetic resonance imaging) and brown adipose tissue biopsies in a subsample of 20 participants. The data will be expressed as mean and standard deviation and the variables compared by the Student t test or ANOVA for repeated measures.
Detailed description
- HYPOTHESIS The effects of fatty acids consumption on brown / beige adipose tissue have not yet been explored in humans. However, studies that evaluated the effects of saturated fatty acid replacement by monounsaturated fatty acids (MUFAs) or polyunsaturated fatty acids (PUFAs) on animal and human models have observed an improvement in cardiovascular risk factors, such as reduction of subclinical inflammation, improvement of lipid profile and increase in insulin sensitivity. The mechanisms by which these fatty acids act in the improvement of risk factors have not been completely clarified and it is possible that there is an association between the reduction of cardiovascular risk factors and the activation of brown / beige adipose tissue. Our hypothesis is that consuming extra virgin olive oil in high amounts for one month will promote increased brown adipose tissue (BAT) activity of the participants and improve the cardiovascular risk profile, as assessed by inflammatory markers. It is possible that the response of lean and obese subjects to dietary intervention is different and that the behavior of BAT is not equal in both groups.
- OBJECTIVE To evaluate the impact of the consumption of large amounts of extra virgin olive oil (source of monounsaturated fatty acids) on the activity of brown / beige adipose tissue in lean and obese humans. 2.1 Specific objectives • To investigate the activity of brown and beige adipose tissue by FDG PET / RMI, before and after four weeks of intervention with high amount of extra virgin olive oil; • To evaluate the expression of BAT activity markers: uncoupling protein 1 (UCP-1), PR domain containing 16 (PRDM16), Peroxisome proliferator-activated receptor gamma coactivator 1-alpha (PGC-1α), iodothyronine deiodinase 2 (Dio2) in mononuclear cells in the whole sample;
- To evaluate levels of fatty acids in the blood by gas chromatography, before and after the intervention to evaluate changes in fatty acid intake;
- To evaluate concentrations of pro and anti-inflammatory cytokines in the blood before and after 4 weeks of intervention: tumor necrosis factor alpha (TNF-α), interleukin 1-beta (IL1β), Monocyte Chemoattractant Protein-1 (MCP-1), interleukin-6 and interleukin-10);
- To evaluate the effects of interventions on metabolic markers before and after the intervention: leptin, insulin, glucose, total cholesterol and fractions, triglycerides;
- To evaluate the effects of the intervention on anthropometry (weight, abdominal circumference) and on the body composition evaluated by Dual-energy X-ray absorptiometry (DXA);
- To evaluate the effects of dietary interventions on brain activity (by PET/MRi) in a subsample of 15 individuals.
- MATERIALS AND METHODS This will be an open clinical trial lasting for four weeks. The study consists of two data collections before and after a 4-week dietary intervention in which participants will be required to consume extra-virgin olive oil provided by the researchers. The collection of socio demographic, dietary and physical activity data, as well as the PET / MRI and the blood collections of 50 participants will be carried out at the Nuclear Medicine Center of the Medical School of the University of São Paulo. Bone densitometry (DXA) will be performed at the School of Public Health of the University of São Paulo. Selection of participants: The estimated number of individuals with a detectable brown adipose tissue (50) is 50%, with the proportion of individuals with detectable brown adipose tissue. It will include 15 obese individuals (degree I obesity) and 35 control subjects (normal weight individuals). Participants will be selected through print and electronic media.
- Inclusion criteria For the group with obesity: Both genders, age between 25 and 40 years, BMI ≥ 30 and <35 kg / m2. For the normal weight group (control): Both genders, age between 25 and 40 years, BMI <25 kg / m2.
- Exclusion Criteria
- Residing outside of São Paulo / Campinas; 2) pregnant women; 3) patients with severe or non-stabilized neurological or psychiatric problems; 4) use of anti-obesity or lipid-lowering medication; 5) use of adrenergic or benzodiazepine drugs; 6) individuals with neoplasms, transmissible and rheumatic diseases, hepatic or renal insufficiency, untreated thyroid dysfunction; Diabetes mellitus; 7) change of more than 5% of body weight in the last six months; 8) to be carrying out some kind of diet or modification in the usual dietary pattern; 9) have metal prostheses.
- Design This is an open clinical trial with a total duration of four weeks. Obese and controls participants will be enrolled into a dietary intervention for 4 weeks with extra virgin olive oil (MUFA rich). Extra-virgin olive oil (2 liters) is provided to participants and the researchers adivice the participants to use the oil in all preparations during the four weeks. Before and after each intervention period the following data will be collected:
- Food consumption: 24-hour recall (before and after dietary intervention) and 3-day food diary;
- Physical activity data: International Physical Activity Questionnaire (IPAQ);
- Evaluation of brown / beige adipose tissue volume and activity: Positron emission tomography with fluoride-18-labeled fluorodeoxyglucose (18F-FDG) in combination with magnetic resonance (PET / MRi). For the FDG PET / RMI the participants will be allocated in a room with controlled temperature (19 degrees), with light clothes and a cooling vest for 2 hours.
- Body composition assessment: Weight (digital scale) and height (fixed stadiometer);; abdominal circumference; body composition: by Dual-energy X-ray absorptiometry (DXA);
- Biochemical dosages: plasma glucose, triglycerides, total cholesterol and HDL-c will be determined routinely and inflammatory markers will be determined by enzyme-linked immunosorbent assay (ELISA);
- Expression of UCP-1, PGC-1α, PRDM16 and Dio2 will be performed by Real-Time Polymerase chain reaction (RT-PCR);
- Composition of fatty acids in plasma will be determined by gas chromatography;
- Brain activity: will be performed in a subsample of 15 individuals using 18F-FDG PET/MRi.
- Statistical analysis Data will be expressed as mean and standard deviation and the variables compared by Student's t-test or ANOVA for repeated measures.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All subjects receive a dietary intervention with olive oil.
| Arm | Type | Receives |
|---|---|---|
| obese individuals | Active comparator | Dietary Supplement: Extra virgin olive oilIndividuals with BMI between 30 and 35 kg/m2 will be included in this group and will receive 4 weeks of extra virgin olive oil. Before and after the intervention period data regarding dietary intake and physical activity, brown/beige adipose tissue activity, body composition (DXA), lipid profile and inflammatory markers and brain activity (18F-FDG PET/MRI; in a subsample of 5 obese individuals)will be collected. |
| normal weight individuals | Active comparator | Dietary Supplement: Extra virgin olive oilIndividuals with BMI between 18.5 and 24.99 kg/m2 will be included in this group and will receive 4 weeks of extra virgin olive oil. Before and after the intervention period data regarding dietary intake and physical activity, brown/beige adipose tissue activity, body composition (DXA), lipid profile and inflammatory markers and and brain activity (18F-FDG PET/MRI; in a subsample of 10 normal weight individuals) will be collected. |
Who may qualify
- Ages
- 25 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Living outside of São Paulo;
- pregnant women;
- patients with severe or non-stabilized neurological or psychiatric problems;
- use of anti-obesity or lipid-lowering medication;
- use of adrenergic or benzodiazepine drugs;
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 |
|---|---|---|
| Extra virgin olive oil2 liters of extra virgin olive oil will be given to participants to include/use in their daily foods. | Dietary supplement | normal weight individuals, obese individuals |
Primary outcome
Brown adipose tissue activity measured by increase in mean standardized disposal value (SUV)
Time frame: Four weeks
We will investigate whether 4 weeks of olive oil consumption can increase the activity of brown adipose tissue measured by mean standardized disposal value (volume) using magnetic resonance imaging
3 secondary outcomes
Hypothalamic inflammation
Time frame: Four weeks
Lipid profile
Time frame: Four weeks
Inflammatory markers
Time frame: Four weeks
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 4 Nov 2020.
- Background: PubMed 19357405van Marken Lichtenbelt WD, Vanhommerig JW, Smulders NM, Drossaerts JM, Kemerink GJ, Bouvy ND, Schrauwen P, Teule GJ. Cold-activated brown adipose tissue in healthy men. N Engl J Med. 2009 Apr 9;360(15):1500-8. doi: 10.1056/NEJMoa0808718.
- Background: PubMed 22535970Vijgen GH, Bouvy ND, Teule GJ, Brans B, Hoeks J, Schrauwen P, van Marken Lichtenbelt WD. Increase in brown adipose tissue activity after weight loss in morbidly obese subjects. J Clin Endocrinol Metab. 2012 Jul;97(7):E1229-33. doi: 10.1210/jc.2012-1289. Epub 2012 Apr 24.
- Background: PubMed 25920777Chondronikola M, Annamalai P, Chao T, Porter C, Saraf MK, Cesani F, Sidossis LS. A percutaneous needle biopsy technique for sampling the supraclavicular brown adipose tissue depot of humans. Int J Obes (Lond). 2015 Oct;39(10):1561-4. doi: 10.1038/ijo.2015.76. Epub 2015 Apr 29.
- Derived from this study: PubMed 33180910Monfort-Pires M, U-Din M, Nogueira GA, de Almeida-Faria J, Sidarta-Oliveira D, Sant'Ana MR, De Lima-Junior JC, Cintra DE, de Souza HP, Ferreira SRG, Sapienza MT, Virtanen KA, Velloso LA. Short Dietary Intervention with Olive Oil Increases Brown Adipose Tissue Activity in Lean but not Overweight Subjects. J Clin Endocrinol Metab. 2021 Jan 23;106(2):472-484. doi: 10.1210/clinem/dgaa824.
- 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.
Milena Monfort-Pires, PhD principal investigator
University of Campinas
Licio A Velloso, Professor study director
University of Campinas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extra virgin olive oil in people with Obese, run by University of Campinas, Brazil 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 0 inclusion and 7 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 4 Nov 2020. 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?
Brown adipose tissue activity measured by increase in mean standardized disposal value (SUV) (time frame: Four weeks). 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 NCT03024359, which also lists 4 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 4 Nov 2020.