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Olive Oil and Nampt on Postprandial Inflammation and Atherosclerosis in the Setting of Metabolic Syndrome (OLNAMS)

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ClinicalTrials.gov Identifier: NCT02061267
Recruitment Status : Completed
First Posted : February 12, 2014
Last Update Posted : March 13, 2019
Sponsor:
Information provided by (Responsible Party):
Francisco Jose Garcia Muriana, National Research Council, Spain

Brief Summary:

The metabolic syndrome may be defined as the constellation of cardiovascular disease (CVD) risk factors that comprises obesity, type 2 diabetes, dyslipidemia, and hypertension. Lack of habitual physical activity and certain dietary patterns, including high-saturated fatty acids (SFA) intake, contribute to increase the risk of CVD, whereas the greatest risk reduction is related with monounsaturated fatty acids (MUFA), mainly from olive oil, and omega-3 polyunsaturated fatty acids (PUFA). Vitamin B3, as a major substrate for nicotinamide phosphoribosyltransferase (NAMPT), has also emerged as a nutritional intervention strategy for prevention of CVD.

NAMPT has been shown to exert activities of central importance to cellular energetics and innate immunity. Within the cell, NAMPT is the rate-limiting step in a salvage pathway of nicotinamide adenine dinucleotide (NAD+) biosynthesis. By virtue of this role, it can regulate cellular levels of NAD+ and thereby NAD+-consuming enzymes. NAMPT is also released by a variety of cells, and elevated levels can be found in the systemic circulation of subjects with a range of inflammatory disorders.

Recent evidences suggest that, primarily due to its high MUFA content, olive oil is useful as an optimal fat for the modulation of CVD risk factors in the postprandial state. In addition, NAMPT has been shown to correlate with triglycerides in the fasting plasma, and a potential regulatory role for fatty acids on NAMPT expression has been proposed.

The global aim of the project is to assess whether olive oil (MUFA), compared to other dietary fatty acids (SFA and omega-3 PUFA) and in association with vitamin B3 could have benefits on NAMPT-related inflammation and atherosclerosis. We hope to provide important novel insights on the relationship among dietary fatty acids, NAD+ metabolism, and metabolic syndrome. This aim is expected to be achieved in one principal objective:

To elucidate the influence of olive oil (MUFA), butter (SFA) or fish oil (omega-3 PUFA) meals supplemented by vitamin B3 on postprandial NAMPT modulation and its involvement on leukocyte inflammatory response in subjects with metabolic syndrome.


Condition or disease Intervention/treatment Phase
Metabolic Syndrome Dietary Supplement: Niacin Dietary Supplement: Saturated meal Dietary Supplement: Monounsaturated meal Dietary Supplement: Polyunsaturated meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: OLIVE OIL ON NAMPT AND ITS RELATION WITH POSTPRANDIAL INFLAMMATION AND ATHEROSCLEROSIS IN THE SETTING OF METABOLIC SYNDROME. The OLNAMS Project
Actual Study Start Date : January 1, 2012
Actual Primary Completion Date : December 2013
Actual Study Completion Date : June 30, 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Niacin Control
The subjects will receive a vitamin B3 supplement (2 g)
Dietary Supplement: Niacin
The subjects will receive a vitamin B3 supplement (2 g)
Other Names:
  • Vitamine B3
  • Nicotinic Acid

Experimental: Niacin + SAT
The subjects will receive a vitamin B3 supplement (2 g) and a test meal with high-fat (containing 72% saturated fat, 22% carbohydrate, and 6% protein)
Dietary Supplement: Niacin
The subjects will receive a vitamin B3 supplement (2 g)
Other Names:
  • Vitamine B3
  • Nicotinic Acid

Dietary Supplement: Saturated meal
Test meal with high-fat (containing 72% saturated fat, 22% carbohydrate, and 6% protein)
Other Names:
  • Butter
  • Saturated fat

Experimental: Niacin + ROO
The subjects will receive a vitamin B3 supplement (2 g) and a test meal with high-fat (containing 72% monounsaturated fat, 22% carbohydrate, and 6% protein)
Dietary Supplement: Niacin
The subjects will receive a vitamin B3 supplement (2 g)
Other Names:
  • Vitamine B3
  • Nicotinic Acid

Dietary Supplement: Monounsaturated meal
Test meal with high-fat (containing 72% monounsaturated fat, 22% carbohydrate, and 6% protein)
Other Names:
  • Refined olive oil
  • olive oil
  • oleic acid

Experimental: Niacin + O3
The subjects will receive a vitamin B3 supplement (2 g) and a test meal with high-fat (containing 72% polyunsaturated omega-3 fat, 22% carbohydrate, and 6% protein)
Dietary Supplement: Niacin
The subjects will receive a vitamin B3 supplement (2 g)
Other Names:
  • Vitamine B3
  • Nicotinic Acid

Dietary Supplement: Polyunsaturated meal
Test meal with high-fat (containing 72% polyunsaturated omega-3 fat, 22% carbohydrate, and 6% protein)
Other Names:
  • Fish oil
  • Omega-3
  • DHA
  • EPA




Primary Outcome Measures :
  1. Evolution of Metabolic parameters in postprandial state [ Time Frame: t = 0, 2, 3, 4 and 6 hours ]
    Glucose, insulin, C-peptide, triglyceride, and NEFA levels in plasma will be measured at several time-points postprandially (t = 0, 2, 3, 4, and 6 h) using routine biochemical procedures. Different empiric indices of postprandial β-cell function and insulin sensitivity will be determined.

  2. Evolution of Inflammatory markers in postprandial state [ Time Frame: t = 0, 2, 3, 4 and 6 hours ]
    Inflammatory markers will be measured in plasma at several time-points postprandially (t = 0, 2, 3, 4, and 6 h) using appropriate methods (EIA, ELISA, and/or Bioplex multiplex system), and will include NAMPT, the acute phase protein (hsCRP), PAI-1, fibrinogen, transferrin, albumin, MPO (myeloperoxidase), and cytokines such as TNFα, IL-1β, IL-6, IL-8, IL-10, ICAM-1, MCP-1, leptin, and adiponectin, among other markers. For NAD+ content in plasma at fasting and postprandially, we will add 0.5 M ice-cold HClO4 to samples; after 2 min, we will collect 100 μL of supernatants by centrifugation at 3,000 g for 5 min, add 20 μL K2HPO4 (1 M) with cooling on ice and adjust pH to 7.2-7.4 with KOH. We will add 50 μL of supernatant to the reaction mixture containing 0.1 M sodiumpyrophosphate-semicarbazid (pH 8.8), absolute ethanol, and dH2O. We will assess NAD+ spectrophotometrically at 339 nm at 25 °C, as a mean difference in absorbance before and 6 min after addition of alcohol dehydrogenase.

  3. Pharmacokinetic of Niacin and its metabolites [ Time Frame: t = 0, 2, 3, 4 and 6 hours. ]
    Quantitation of nicotinic acid and its metabolites (nicotinamide, nicotinuric acid, and N-methyl-2-pyridone-5-carboxamide) will be assessed in postprandial plasma by LC-MS/MS.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • clinical diagnosis of metabolic syndrome

Exclusion Criteria:

  • Subjects will be excluded if, allergic to dairy products, allergic to fish oil, vegetarian, tobacco smoker, current or recent (<4 wk) use of fish oil supplements or more than four times fish/week, received innoculations within 2 mo of starting the study or planned to during the study, donated or intended to donate blood from 2 mo before the study till 2 mo after the study, unstable body weight (no weight gain/loss >3 kg), medical condition that can interfere with the study outcome (i.e., biochemical evidence of active heart disease, renal impairment, hypothyroidism, liver dysfunction, etc.), use of medications know to interfere with glucose homeostasis or lipid metabolism, use of anti-inflammatory medication, hormone or cytokine or growth factor therapies, abuse of drugs and/or alcohol, participation in another biomedical study within 1 mo before the first screening visit, or not wanting to be informed about chance-findings during screening. Another exclusion criteria will be severe diabetes, which requires application of insuin and diabetes-related complications.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061267


Locations
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Spain
Instituto de la Grasa, CSIC
Seville, Spain, 41012
Sponsors and Collaborators
National Research Council, Spain
Investigators
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Principal Investigator: Francisco José García Muriana, phD National Research Counsil

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Responsible Party: Francisco Jose Garcia Muriana, Scientific Research Francisco Jose Garcia Muriana, National Research Council, Spain
ClinicalTrials.gov Identifier: NCT02061267     History of Changes
Other Study ID Numbers: AGL2011-29008
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: March 13, 2019
Last Verified: March 2019

Keywords provided by Francisco Jose Garcia Muriana, National Research Council, Spain:
Metabolic Syndrome
Olive Oil
Niacin

Additional relevant MeSH terms:
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Nicotinic Acids
Atherosclerosis
Metabolic Syndrome
Syndrome
Inflammation
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Vitamins
Niacin
Niacinamide
Vitamin B Complex
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents