Overview

This trial is active, not recruiting.

Condition metabolic syndrome
Treatments niacin, saturated meal, monounsaturated meal, polyunsaturated meal
Sponsor National Research Council, Spain
Start date January 2012
End date December 2013
Trial size 40 participants
Trial identifier NCT02061267, AGL2011-29008

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Experimental)
The subjects will receive a vitamin B3 supplement (2 g)
niacin Vitamine B3
The subjects will receive a vitamin B3 supplement (2 g)
(Experimental)
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)
niacin Vitamine B3
The subjects will receive a vitamin B3 supplement (2 g)
saturated meal Butter
Test meal with high-fat (containing 72% saturated fat, 22% carbohydrate, and 6% protein)
(Experimental)
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)
niacin Vitamine B3
The subjects will receive a vitamin B3 supplement (2 g)
monounsaturated meal Refined olive oil
Test meal with high-fat (containing 72% monounsaturated fat, 22% carbohydrate, and 6% protein)
(Experimental)
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)
niacin Vitamine B3
The subjects will receive a vitamin B3 supplement (2 g)
polyunsaturated meal Fish oil
Test meal with high-fat (containing 72% polyunsaturated omega-3 fat, 22% carbohydrate, and 6% protein)

Primary Outcomes

Measure
Evolution of Metabolic parameters in postprandial state
time frame: t = 0, 2, 3, 4 and 6 hours
Evolution of Inflammatory markers in postprandial state
time frame: t = 0, 2, 3, 4 and 6 hours
Pharmacokinetic of Niacin and its metabolites
time frame: t = 0, 2, 3, 4 and 6 hours.

Eligibility Criteria

Male participants at least 18 years old.

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.

Additional Information

Official title OLIVE OIL ON NAMPT AND ITS RELATION WITH POSTPRANDIAL INFLAMMATION AND ATHEROSCLEROSIS IN THE SETTING OF METABOLIC SYNDROME. The OLNAMS Project
Principal investigator Francisco José García Muriana, phD
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by National Research Council, Spain.