Suppression of Postprandial Monocyte Activation by Blueberries or Docosahexaenoic Acid in Humans
NCT ID: NCT02472171
Last Updated: 2018-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2015-06-30
2017-11-30
Brief Summary
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Detailed Description
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The experimental procedures and the study activities will last for approximately 9 weeks. There will be three test days, scheduled 4 weeks apart. On the test days there will be four blood draws (one fasting blood draw and three postprandial blood draws at 1-hour, 3-hour and 6-hour after breakfast, respectively). Three endothelial function measurements (EndoPAT) will be carried out each test day. A pre-test dinner meal will be provided to the subject to eat the night before each test day. Subjects will be asked to follow and record a low antioxidant and polyphenol diet of their own choosing for 3 days prior to each test day. This includes minimizing tea, wine, coffee, chocolate, fruits, vegetables, whole grains, soy, herbs, spices, condiments, and fatty fish. All volunteers will participate in all test days, receiving in randomize cross-over fashion the following treatments:
A. High saturated fat diet, placebo powder, sunflower oil. B. High saturated fat diet, blueberry powder, sunflower oil. C. High saturated fat diet, placebo powder, DHA.
The high saturated fat meal will be identical in all treatments and may contain tortilla, cheddar cheese, beef sausage, scrambled eggs, and a smoothie style drink containing sugar, vanilla extract, oil, whole milk yogurt and the ingredients for masking treatments. The placebo powder may contain Beneprotein® (Nestlé Nutrition), Benefiber® (Novartis), oil, sugar, artificial food-grade blueberry flavor, and artificial food-grade blue and red colors. The blueberry powder (equivalent to four 1/2 cup servings) will be obtained from the U.S. Highbush Blueberry Council (Folsom, CA). The DHA will be obtained from Martek Biosciences. Blueberry or placebo powder and the DHA or sunflower oil will be combined into a blueberry flavored smoothie style drink. Neither the study subjects or the investigators will know which treatment is provided on which test day.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Group 1
Order of treatments:
A. High saturated fat meal, placebo powder and sunflower oil B. High saturated fat meal, blueberry powder and sunflower oil C. High saturated fat meal, placebo powder and DHA
High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal with a blueberry flavored shake and sunflower oil
High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal with blueberry powder shake and sunflower oil
High saturated fat meal, placebo powder and DHA
High saturated fat meal with a blueberry flavored shake and DHA
Group 2
Order of treatments:
A. High saturated fat meal, placebo powder and sunflower oil C. High saturated fat meal, placebo powder and DHA B. High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal with a blueberry flavored shake and sunflower oil
High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal with blueberry powder shake and sunflower oil
High saturated fat meal, placebo powder and DHA
High saturated fat meal with a blueberry flavored shake and DHA
Group 3
Order of treatments:
B. High saturated fat meal, blueberry powder and sunflower oil A. High saturated fat meal, placebo powder and sunflower oil C. High saturated fat meal, placebo powder and DHA
High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal with a blueberry flavored shake and sunflower oil
High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal with blueberry powder shake and sunflower oil
High saturated fat meal, placebo powder and DHA
High saturated fat meal with a blueberry flavored shake and DHA
Group 4
Order of treatments:
B. High saturated fat meal, blueberry powder and sunflower oil C. High saturated fat meal, placebo powder and DHA A. High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal with a blueberry flavored shake and sunflower oil
High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal with blueberry powder shake and sunflower oil
High saturated fat meal, placebo powder and DHA
High saturated fat meal with a blueberry flavored shake and DHA
Group 5
Order of treatments:
C. High saturated fat meal, placebo powder and DHA B. High saturated fat meal, blueberry powder and sunflower oil A. High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal with a blueberry flavored shake and sunflower oil
High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal with blueberry powder shake and sunflower oil
High saturated fat meal, placebo powder and DHA
High saturated fat meal with a blueberry flavored shake and DHA
Group 6
Order of treatments:
C. High saturated fat meal, placebo powder and DHA A. High saturated fat meal, placebo powder and sunflower oil B. High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal with a blueberry flavored shake and sunflower oil
High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal with blueberry powder shake and sunflower oil
High saturated fat meal, placebo powder and DHA
High saturated fat meal with a blueberry flavored shake and DHA
Interventions
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High saturated fat meal, placebo powder and sunflower oil
High saturated fat meal with a blueberry flavored shake and sunflower oil
High saturated fat meal, blueberry powder and sunflower oil
High saturated fat meal with blueberry powder shake and sunflower oil
High saturated fat meal, placebo powder and DHA
High saturated fat meal with a blueberry flavored shake and DHA
Eligibility Criteria
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Inclusion Criteria
* Complete Blood Count (CBC) within normal limits
* Blood chemistry panel within normal limits
Exclusion Criteria
* smoke or use tobacco products
* consume more than one alcoholic beverage per day (defined as 1 oz. distilled liquor, 3 oz. wine, or 12 oz. beer)
* taking any cholesterol lowering
* taking blood pressure medication
* taking non-steroidal anti-inflammatory drugs (NSAIDS) more than once a week and for 3 days before each test day
* taking steroids for asthma or other inflammatory states
* taking thyroid-regulating drugs
* taking over-the-counter weight loss products
* allergies or sensitivities to foods or ingredients in the test meals, especially blueberries or DHA
* taking fish or algae oil or other dietary supplements and unwilling to stop the supplements for the duration of the study (multivitamin is OK)
* Women who are pregnant, lactating or planning a pregnancy
* fasting blood cholesterol greater than 240 mg/dL
* fasting blood triglyceride greater than 300mg/dL
* hemoglobin less than 11.5 mg/dL
* blood pressure greater than 140/90 mmHg
* metabolic diseases such as diabetes mellitus, hypothyroidism, kidney disease, liver disease, bleeding disorders, autoimmune diseases, other inflammatory disease, or cancer unless greater than 5 years remission
18 Years
60 Years
ALL
Yes
Sponsors
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University of California, Davis
OTHER
USDA, Western Human Nutrition Research Center
FED
Responsible Party
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Principal Investigators
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Daniel Hwang, PhD
Role: PRINCIPAL_INVESTIGATOR
USDA, ARS, Western Human Nutrition Research Center
Locations
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USDA, ARS, Western Human Nutrition Research Center
Davis, California, United States
Countries
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References
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Mo Z, Huang S, Burnett DJ, Rutledge JC, Hwang DH. Endotoxin May Not Be the Major Cause of Postprandial Inflammation in Adults Who Consume a Single High-Fat or Moderately High-Fat Meal. J Nutr. 2020 May 1;150(5):1303-1312. doi: 10.1093/jn/nxaa003.
Other Identifiers
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2013-03477
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
537073
Identifier Type: -
Identifier Source: org_study_id
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