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

NCT ID: NCT02061267

Last Updated: 2019-03-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-01
• Study Completion Date: 2015-06-30

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Niacin Control

The subjects will receive a vitamin B3 supplement (2 g)

Group Type: EXPERIMENTAL

Niacin

Intervention Type: DIETARY_SUPPLEMENT

The subjects will receive a vitamin B3 supplement (2 g)

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)

Group Type: EXPERIMENTAL

Niacin

Intervention Type: DIETARY_SUPPLEMENT

The subjects will receive a vitamin B3 supplement (2 g)

Saturated meal

Intervention Type: DIETARY_SUPPLEMENT

Test meal with high-fat (containing 72% saturated fat, 22% carbohydrate, and 6% protein)

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)

Group Type: EXPERIMENTAL

Niacin

Intervention Type: DIETARY_SUPPLEMENT

The subjects will receive a vitamin B3 supplement (2 g)

Monounsaturated meal

Intervention Type: DIETARY_SUPPLEMENT

Test meal with high-fat (containing 72% monounsaturated fat, 22% carbohydrate, and 6% protein)

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)

Group Type: EXPERIMENTAL

Niacin

Intervention Type: DIETARY_SUPPLEMENT

The subjects will receive a vitamin B3 supplement (2 g)

Polyunsaturated meal

Intervention Type: DIETARY_SUPPLEMENT

Test meal with high-fat (containing 72% polyunsaturated omega-3 fat, 22% carbohydrate, and 6% protein)

Interventions

Niacin

The subjects will receive a vitamin B3 supplement (2 g)

Intervention Type: DIETARY_SUPPLEMENT

Saturated meal

Test meal with high-fat (containing 72% saturated fat, 22% carbohydrate, and 6% protein)

Intervention Type: DIETARY_SUPPLEMENT

Monounsaturated meal

Test meal with high-fat (containing 72% monounsaturated fat, 22% carbohydrate, and 6% protein)

Intervention Type: DIETARY_SUPPLEMENT

Polyunsaturated meal

Test meal with high-fat (containing 72% polyunsaturated omega-3 fat, 22% carbohydrate, and 6% protein)

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Vitamine B3; Nicotinic Acid; Butter; Saturated fat; Refined olive oil; olive oil; oleic acid; Fish oil; Omega-3; DHA; EPA

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of metabolic syndrome

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Research Council, Spain

OTHER_GOV

Sponsor Role: lead

Responsible Party

Francisco Jose Garcia Muriana

Scientific Research Francisco Jose Garcia Muriana

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francisco José García Muriana, phD

Role: PRINCIPAL_INVESTIGATOR

National Research Counsil

Locations

Instituto de la Grasa, CSIC

Seville, , Spain

Countries

Spain

Other Identifiers

AGL2011-29008

Identifier Type: -

Identifier Source: org_study_id