search
Back to results

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

Primary Purpose

Inflammation

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breakfast meal with placebo powder
Breakfast meal with 2 serving equivalents of blueberries
Breakfast meal with 4 serving equivalents of blueberries
Sponsored by
USDA, Western Human Nutrition Research Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional basic science trial for Inflammation focused on measuring Toll like receptors, Inflammation, Anthocyanins, Blueberries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • USDA, ARS, Western Human Nutrition Research Center

Outcomes

Primary Outcome Measures

Monocyte activation in whole blood
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
Peripheral blood mononuclear (PBMC) activation in response to autologous fasting and postprandial serum will be analyzed for IL-1beta secretion and other cytokines.

Full Information

First Posted
May 4, 2012
Last Updated
March 20, 2015
Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
U.S. Highbush Blueberry Council
search

1. Study Identification

Unique Protocol Identification Number
NCT01594008
Brief Title
The Effects of Antioxidants in Blueberry Powder on Inflammation Induced by a Single High Fat Meal.
Acronym
FL89
Official Title
Does Blueberry Intake Alleviate Postprandial Lipemia-induced Inflammation?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
USDA, Western Human Nutrition Research Center
Collaborators
U.S. Highbush Blueberry Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
This study was designed as a single blind, placebo-controlled crossover study. Subjects were never told what dose of blueberry powder was given. Researchers handling samples and data did not know what dose of blueberry powder subjects received on test day 2 or 3. The frozen blueberry yogurt supplemented with either control or blueberry powder was coded by letter, and samples were coded by test day: since the control powder was given on the first day to all subjects, the laboratory staff analyzing the samples would have known that the first day samples were from the subjects receiving the control powder.The provision of the control powder on the first day to all subjects was done to mitigate potential carry over effects of the blueberry powder.The randomization plan for the two doses (two vs four servings) of blueberry powder was uploaded into a spreadsheet of which only the registered dietitian, the Human Studies Manager, and the Metabolic Kitchen and Human Feeding Laboratory staff had access. Subjects were instructed by a registered dietitian to follow a low polyphenol and omega-3 diet and limit consumption of fruits, vegetables, soy, fatty fish (e.g. salmon), whole grains, nuts, coffee, tea, and chocolate starting 3 days prior to each test day. The night before each test day, subjects were required to eat a standardized dinner provided by the WHNRC. Since a previous meal may impact the postprandial response of the next, subjects were fed a dinner that consisted of a burrito with tortilla, chicken, cheese, oil, and pinto beans as well as yogurt and lemonade. On each test day, subjects arrived at the WHNRC after a 12-hour overnight fast. Subjects had their body temperature, blood pressure, and weight measured, and then had blood withdrawn. Subjects were fed the MHF breakfast supplemented with a frozen yogurt containing either control or blueberry powder. Subjects were given 20 minutes to consume the entire breakfast. Subjects were instructed not to eat or drink anything other than plain water. Three and one-half hours following consumption of the test meal each subject returned to the WHNRC for a postprandial blood draw. Postprandial hypertriglyceridemia peaks on average 3.5 hours after the consumption of a high fat breakfast, thus the 3.5 hour blood draw provides the highest concentration of TGRL. Subjects were allowed to return to their normal activities after the morning meal before the postprandial blood draw. Following the postprandial blood draw, subjects were allowed to return to their normal dietary habits until three days prior to their next test day. Subjects were fed the control powder on their first test day. On the second and third test days subjects were fed varying amounts of the blueberry powder that were equivalent to two or four servings of fresh blueberries (24.1 g and 48.2 g of blueberry powder, respectively) in a random order.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation
Keywords
Toll like receptors, Inflammation, Anthocyanins, Blueberries

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
N/A
Enrollment
43 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Other
Intervention Name(s)
Breakfast meal with placebo powder
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breakfast meal with 2 serving equivalents of blueberries
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Breakfast meal with 4 serving equivalents of blueberries
Intervention Description
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.
Primary Outcome Measure Information:
Title
Monocyte activation in whole blood
Description
Monocyte activation assay in whole blood will be measured by IL-1Beta secretion and other cytokines (TNF-alpha, INFγ).
Time Frame
Change in activation from 0 to 3.5 hours
Secondary Outcome Measure Information:
Title
Peripheral blood mononuclear (PBMC) activation
Description
Peripheral blood mononuclear (PBMC) activation in response to autologous fasting and postprandial serum will be analyzed for IL-1beta secretion and other cytokines.
Time Frame
Change from 0 to 3.5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Hwang, PhD
Organizational Affiliation
USDA, ARS, Western Human Nutrition Research Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John Rutledge, MD
Organizational Affiliation
University of California, Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
USDA, ARS, Western Human Nutrition Research Center
City
Davis
State/Province
California
ZIP/Postal Code
95616
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
27306892
Citation
Ono-Moore KD, Snodgrass RG, Huang S, Singh S, Freytag TL, Burnett DJ, Bonnel EL, Woodhouse LR, Zunino SJ, Peerson JM, Lee JY, Rutledge JC, Hwang DH. Postprandial Inflammatory Responses and Free Fatty Acids in Plasma of Adults Who Consumed a Moderately High-Fat Breakfast with and without Blueberry Powder in a Randomized Placebo-Controlled Trial. J Nutr. 2016 Jul;146(7):1411-9. doi: 10.3945/jn.115.223909. Epub 2016 Jun 15.
Results Reference
derived
Links:
URL
http://www.ars.usda.gov/Main/docs.htm?docid=11240
Description
USDA Western Human Nutrition Research Center

Learn more about this trial

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

We'll reach out to this number within 24 hrs