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
  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:


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:
    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.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
U.S. 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:
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 August 01, 2014