The Effects of Antioxidants in Blueberry Powder on Inflammation Induced by a Single High Fat Meal. - Full Text View

Purpose

The goal of the study is to find out whether a high fat meal increases blood lipids and causes monocyte (white blood cell) activation, and whether blueberry intake at the same meal lessens monocyte activation in healthy people.

Condition	Intervention
Inflammation	Other: Breakfast meal with placebo powder Other: Breakfast meal with 2 serving equivalents of blueberries Other: Breakfast meal with 4 serving equivalents of blueberries

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Basic Science
Official Title:	Does Blueberry Intake Alleviate Postprandial Lipemia-induced Inflammation?

Resource links provided by NLM:

MedlinePlus related topics: Antioxidants

Drug Information available for: Vaccinium corymbosum

U.S. FDA Resources

Further study details as provided by USDA, Western Human Nutrition Research Center:

Primary Outcome Measures:

Monocyte activation in whole blood [ Time Frame: Change in activation from 0 to 3.5 hours ] [ Designated as safety issue: No ]
Monocyte activation assay in whole blood will be measured by IL-1Beta secretion and other cytokines (TNF-alpha, INFγ).

Secondary Outcome Measures:

Peripheral blood mononuclear (PBMC) activation [ Time Frame: Change from 0 to 3.5 hours ] [ Designated as safety issue: No ]
Peripheral blood mononuclear (PBMC) activation in response to autologous fasting and postprandial serum will be analyzed for IL-1beta secretion and other cytokines.

Enrollment:	43
Study Start Date:	January 2012
Study Completion Date:	May 2013
Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Intervention Details:

Zero serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and placebo powder.

Two serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and freeze-dried blueberry powder.

Four serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and freeze-dried blueberry powder.

Detailed Description:

The overall goal of the proposed study is to determine whether high fat meal-induced postprandial lipemia causes monocyte activation, and whether concomitant blueberry (i.e. a fruit high in antioxidants, polyphenols) intake alleviates the monocyte activation in healthy human subjects.

The specific aims are: 1) to determine whether propensity to monocyte activation is enhanced by a single high fat meal in healthy subjects, 2) to determine whether postprandial monocyte activation is alleviated with concomitant blueberry intake, and 3) to determine the effects of blueberry supplementation on the global gene expression profile in whole blood samples.

It is hypothesized that consuming fruits (i.e, blueberries) containing a high content of anti-inflammatory polyphenols can suppress high fat diet-induced postprandial inflammation as reflected by activation of blood monocytes.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adults
Able to complete study procedures
Body Mass Index 18 - 24.9 kg/m2

Exclusion Criteria:

Diabetes mellitus
Kidney disease
Liver disease
Thyroid disease
Bleeding disorders
Autoimmune diseases and other inflammatory disease
Cancer, unless in remission for > 5 years
Blood cell counts outside the normal range for age and gender
Blood chemistry panels outside the normal range for age and gender
Blood cholesterol greater than 240 mg/dL
Blood triacylglycerol greater than 300 mg/dL
Hemoglobin less than 11.5 g/dL
Hypertension, blood pressure greater than 140/90 mmHg
Follow a vegetarian diet
Smoke or use tobacco products
Drink more than one alcoholic beverage per day
Taking cholesterol-lowering or blood pressure medication
Daily or regular use of antihistamines
Use of nonsteroidal anti-inflammatory drugs (NSAIDs)
Use of steroids for asthma or other inflammatory diseases
Use of thyroid-regulating drugs
Use of over the counter weight loss products
Known allergies or sensitivities to food ingredients in the test meals
Taking fish or algal oil supplements and unwilling to stop
Pregnant and lactating women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01594008

Locations

United States, California
USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States, 95616

Sponsors and Collaborators

USDA, Western Human Nutrition Research Center

US Highbush Blueberry Council

Investigators

Principal Investigator:	Daniel Hwang, PhD	USDA, ARS, Western Human Nutrition Research Center
Principal Investigator:	John Rutledge, MD	University of California, Davis

More Information

Additional Information:

USDA Western Human Nutrition Research Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:	NCT01594008 History of Changes
Other Study ID Numbers:	250305-3
Study First Received:	May 4, 2012
Last Updated:	May 1, 2013
Health Authority:	United States: Federal Government

Keywords provided by USDA, Western Human Nutrition Research Center:

Toll like receptors
Inflammation
Anthocyanins
Blueberries

Additional relevant MeSH terms:

Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

The Effects of Antioxidants in Blueberry Powder on Inflammation Induced by a Single High Fat Meal. (FL89)