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

This study has been completed.
Sponsor:
Collaborator:
U.S. Highbush Blueberry Council
Information provided by (Responsible Party):
USDA, Western Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT01594008
First received: May 4, 2012
Last updated: May 1, 2013
Last verified: May 2013

May 4, 2012
May 1, 2013
January 2012
May 2013   (final data collection date for primary outcome measure)
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).
Same as current
Complete list of historical versions of study NCT01594008 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Effects of Antioxidants in Blueberry Powder on Inflammation Induced by a Single High Fat Meal.
Does Blueberry Intake Alleviate Postprandial Lipemia-induced Inflammation?

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.

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.

Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Inflammation
  • Other: Breakfast meal with placebo powder
    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.
  • Other: Breakfast meal with 2 serving equivalents of blueberries
    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.
  • Other: Breakfast meal with 4 serving equivalents of blueberries
    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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01594008
250305-3
No
USDA, Western Human Nutrition Research Center
USDA, Western Human Nutrition Research Center
U.S. Highbush Blueberry Council
Principal Investigator: Daniel Hwang, PhD USDA, ARS, Western Human Nutrition Research Center
Principal Investigator: John Rutledge, MD University of California, Davis
USDA, Western Human Nutrition Research Center
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP