Monounsaturated Fatty Acids and Brown/Beige Adipose Tissue in Humans

NCT03024359 | Completed DMC

• 1 other identifier: CAAE: 60698716.1.0000.5404
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Obese

Keywords

Obesity; Brown adipose tissue; Monounsaturated fatty acids; Hypothalamic inflammation

Outcome Measures

Primary Outcomes (1)

• 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

  Four weeks

Secondary Outcomes (3)

• Hypothalamic inflammation

  Four weeks

• Lipid profile

  Four weeks

• Inflammatory markers

  Four weeks

Study Arms (2)

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.

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.

Dietary Supplement: Extra virgin olive oil

Interventions

Extra virgin olive oil DIETARY_SUPPLEMENT

2 liters of extra virgin olive oil will be given to participants to include/use in their daily foods.

normal weight individuals; obese individuals

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Campinas, Brazil: lead
• University of Sao Paulo: collaborator

Study Sites (1)

Faculdade de Ciências Médicas Unicamp

Campinas, São Paulo, 13083-887, Brazil

Location

Related Publications (4)

• 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.

  PMID: 19357405 BACKGROUND

• Vijgen 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.

  PMID: 22535970 BACKGROUND

• Chondronikola 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.

  PMID: 25920777 BACKGROUND

• Monfort-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.

  PMID: 33180910 DERIVED

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Milena Monfort-Pires, PhD

  University of Campinas

  PRINCIPAL INVESTIGATOR

• Licio A Velloso, Professor

  University of Campinas

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: LDN, MSc, PhD

Model Details: All subjects receive a dietary intervention with olive oil.

Study Record Dates

• First Submitted: January 11, 2017
• First Posted: January 18, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: July 1, 2020
• Last Updated: November 4, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)