- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01594008
The Effects of Antioxidants in Blueberry Powder on Inflammation Induced by a Single High Fat Meal. (FL89)
March 20, 2015 updated by: USDA, Western Human Nutrition Research Center
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.
Study Overview
Status
Completed
Conditions
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Subjects had their body temperature, blood pressure, and weight measured, and then had blood withdrawn.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.
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Davis, California, United States, 95616
- USDA, ARS, Western Human Nutrition Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Monocyte activation in whole blood
Time Frame: Change in activation from 0 to 3.5 hours
|
Monocyte activation assay in whole blood will be measured by IL-1Beta secretion and other cytokines (TNF-alpha, INFγ).
|
Change in activation from 0 to 3.5 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Peripheral blood mononuclear (PBMC) activation
Time Frame: Change from 0 to 3.5 hours
|
Peripheral blood mononuclear (PBMC) activation in response to autologous fasting and postprandial serum will be analyzed for IL-1beta secretion and other cytokines.
|
Change from 0 to 3.5 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Daniel Hwang, PhD, USDA, ARS, Western Human Nutrition Research Center
- Principal Investigator: John Rutledge, MD, University of California, Davis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
May 1, 2013
Study Completion (Actual)
May 1, 2013
Study Registration Dates
First Submitted
May 4, 2012
First Submitted That Met QC Criteria
May 4, 2012
First Posted (Estimate)
May 8, 2012
Study Record Updates
Last Update Posted (Estimate)
March 24, 2015
Last Update Submitted That Met QC Criteria
March 20, 2015
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 250305-3
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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