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InflammationNCT02472171

Suppression of Postprandial Monocyte Activation by Blueberries or Docosahexaenoic Acid in Humans

A study testing High saturated fat meal, blueberry powder and sunflower oil in people with Inflammation, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The overall goal of the research study is to determine whether a high-fat meal causes postprandial (after meal) inflammation, and whether eating n-3 polyunsaturated fatty acids (PUFAs) or blueberries that are rich in anti-inflammatory polyphenols suppress the inflammation in healthy people. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Inflammation
What is being tested?
High saturated fat meal, blueberry powder and sunflower oil
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
62 participants
Where
1 siteUnited States
Study dates
Jun 2015to Nov 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Body Mass Index of 18-25 kg/m2
  • Complete Blood Count (CBC) within normal limits
  • Blood chemistry panel within normal limits

Who cannot join

  • following a vegetarian diet
  • 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
Show all 17Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • USDA, ARS, Western Human Nutrition Research Center

    Davis, California, 95616

Other trials in United States

About this study

Official title: Suppression of Postprandial Monocyte Activation by Fruit Rich in Anti-inflammatory Polyphenols or Docosahexaenoic Acid in Humans

The overall goal of the research study is to determine whether a high-fat meal causes postprandial (after meal) inflammation, and whether eating n-3 polyunsaturated fatty acids (PUFAs) or blueberries that are rich in anti-inflammatory polyphenols suppress the inflammation in healthy people.

Read the detailed description

Chronic inflammation is one of the key etiological conditions associated with the development and progression of chronic diseases including Alzheimer's disease, atherosclerotic cardiovascular disease, insulin resistance, obesity and cancer. The causes of chronic inflammation and the role of diet in suppressing inflammation are challenging research questions. Pattern recognition receptors (PRRs), including Toll-like receptors (TLRs), nucleotide-binding oligomerization domain proteins (NODs), and the inflammasome expressed in innate immune cells can be activated by a variety of endogenous molecules derived from tissue injury and diet (in particular saturated fatty acids), eliciting inflammation. Dysregulated induction of PRR-mediated inflammation is known to promote the development of chronic diseases. Previous studies showed that saturated fatty acids can activate toll-like receptor 4 (TLR4) and nucleotide-binding oligomerization domain 2 (NOD2) mediated signaling pathways, whereas, docosahexaenoic acid (DHA), an n-3 polyunsaturated fatty acid, and certain polyphenols (quercetin, luteolin, Epigallocatechin gallate (EGCG), resveratrol) rich in certain fruits and vegetables inhibit TLR4 or NOD2-mediated inflammation. In addition, numerous studies have demonstrated that TLR4 knockout mice were protected from high saturated fat diet-induced inflammation and insulin resistance, suggesting that high fat diet-induced inflammation and insulin resistance are at least partly mediated through the activation of TLR4. Direct evidence of saturated fatty acids derived from a high fat meal activating PRRs in humans has not been demonstrated. Thus, the investigators propose to determine whether saturated fatty acids derived from a high saturated fat meal activate blood monocytes through PRRs and whether dietary DHA and freeze-dried blueberry powder can suppress high saturated fat meal-induced inflammation by inhibiting PRR activation.

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:

  1. 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
Inflammation
Being tested
High saturated fat meal, placebo powder and sunflower oil, High saturated fat meal, blueberry powder and sunflower oil, High saturated fat meal, placebo powder and DHA
Keywords
n-3 polyunsaturated fatty acids, blueberries
Medical subject headings
Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High saturated fat meal, placebo powder and sunflower oilDietary supplement

    High saturated fat meal with a blueberry flavored shake and sunflower oil

  • High saturated fat meal, blueberry powder and sunflower oilDietary supplement

    High saturated fat meal with blueberry powder shake and sunflower oil

  • High saturated fat meal, placebo powder and DHADietary supplement

    High saturated fat meal with a blueberry flavored shake and DHA

Study groups in NCT02472171
Study groupRoleWhat they receive
Group 1ExperimentalOrder 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
Receives: Dietary Supplement: High saturated fat meal, placebo powder and sunflower oil; Dietary Supplement: High saturated fat meal, blueberry powder and sunflower oil; Dietary Supplement: High saturated fat meal, placebo powder and DHA
Group 2ExperimentalOrder 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
Receives: Dietary Supplement: High saturated fat meal, placebo powder and sunflower oil; Dietary Supplement: High saturated fat meal, blueberry powder and sunflower oil; Dietary Supplement: High saturated fat meal, placebo powder and DHA
Group 3ExperimentalOrder 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
Receives: Dietary Supplement: High saturated fat meal, placebo powder and sunflower oil; Dietary Supplement: High saturated fat meal, blueberry powder and sunflower oil; Dietary Supplement: High saturated fat meal, placebo powder and DHA
Group 4ExperimentalOrder 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
Receives: Dietary Supplement: High saturated fat meal, placebo powder and sunflower oil; Dietary Supplement: High saturated fat meal, blueberry powder and sunflower oil; Dietary Supplement: High saturated fat meal, placebo powder and DHA
Group 5ExperimentalOrder 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
Receives: Dietary Supplement: High saturated fat meal, placebo powder and sunflower oil; Dietary Supplement: High saturated fat meal, blueberry powder and sunflower oil; Dietary Supplement: High saturated fat meal, placebo powder and DHA
Group 6ExperimentalOrder 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
Receives: Dietary Supplement: High saturated fat meal, placebo powder and sunflower oil; Dietary Supplement: High saturated fat meal, blueberry powder and sunflower oil; Dietary Supplement: High saturated fat meal, placebo powder and DHA

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Monocyte activation in whole blood

    Change in monocyte activation using monocyte activation assay in whole blood.

    Measured: Measured at 0, 1, 3, and 6 hours after high fat meal with blueberries, DHA or placebo

Secondary outcomes (6)
  1. Change in surface markers for monocyte activation

    Surface markers for monocyte activation will be measured by flow cytometry. Surface markers may include cluster of differentiation (CD) 14 (CD14), CD11c, CD11b and CD62 Ligand (CD62L) to assess monocyte activation and M1 and M2 macrophage marker proteins.

    Measured: Measured at 0, 1, 3, and 6 hours after high fat meal with blueberries, DHA or placebo

  2. Change in systemic inflammation

    Inflammatory mediators measured in whole blood or blood plasma. Inflammatory mediators include cytokines such as Interleukin-1β, Tumor Necrosis Factor-alpha, Interferon-gamma, Interleukin-6, Interleukin-8, Th1, Th2 and Th17.

    Measured: Measured at 0, 1, 3, and 6 hours after high fat meal with blueberries, DHA or placebo

  3. Change in systemic inflammation measured indirectly

    The magnitude of the inhibition of cytokine production after 24 hour incubation of whole blood by endotoxin inhibitor, polymyxin B (PMB), is measured as an indirect assessment of endotoxin concentration. Cytokine concentrations in whole blood after 24 hour incubation with lipoprotein lipase and PMB is used to assess whether increased concentrations of non-esterified fatty acids (NEFA) and saturated fatty acids stimulate cytokine production.

    Measured: Measured at 0, 3, and 6 hours after high fat meal with blueberries, DHA or placebo

  4. Change in gene expression profile in whole blood

    Gene expression measured using RNA sequencing

    Measured: Measured at 0, 1, 3, and 6 hours after high fat meal with blueberries, DHA or placebo

  5. Change in blood lipids

    Lipids, total non-esterified fatty acids, and individual fatty acids measured in blood

    Measured: Measured at 0, 1, 3, and 6 hours after high fat meal with blueberries, DHA or placebo

  6. Change in endothelial function measurements

    Endothelial function measurements will be made using the EndoPAT system, a noninvasive endothelial function assessment tool based on peripheral arterial tone (PAT) signal technology. The change in arterial tone is elicited by creating a hyperemic response induced by local ischemia (by occlusion of the brachial artery for five minutes). The endothelial function is expressed as a Reactive Hyperemia Index as described in the manufacturer's manual.

    Measured: Measured at 0, 3, and 6 hours after high fat meal with blueberries, DHA or placebo

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionNov 2017
  4. Study completionNov 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
62 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02472171
Sponsor's protocol ID
537073
Other IDs
2013-03477
Status last verified
Oct 2018
First submitted
4 Jun 2015
Last updated
30 Oct 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Huang S, Kirschke C, Bosviel R, Mo Z, Bonnel EL, Woodhouse LR, Burnett DJ, Peerson JM, Huang L, Newman JW, Rutledge JC, Hwang DH. Supplementations of docosahexaenoic acid and blueberry suppress a high-fat breakfast-induced postprandial inflammation but only docosahexaenoic acid improves endothelial function in healthy adults: a randomized, double-blind, placebo-controlled crossover intervention study. Nutr Res. 2026 Jul 18;154:12-31. doi: 10.1016/j.nutres.2026.07.008. Online ahead of print.

    PubMed 42696854
  • 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.

    PubMed 32040591

Questions about this trial

What is this clinical trial studying?

A study testing High saturated fat meal, blueberry powder and sunflower oil in people with Inflammation, run by USDA, Western Human Nutrition Research Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Monocyte activation in whole blood (time frame: Measured at 0, 1, 3, and 6 hours after high fat meal with blueberries, DHA or placebo). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02472171, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2018.

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