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

NCT02472171 | Completed

• 2 other identifiers: 5370732013-03477
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Inflammation

Keywords

n-3 polyunsaturated fatty acids; blueberries

Outcome Measures

Primary Outcomes (1)

• Change in Monocyte activation in whole blood

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

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

Secondary Outcomes (6)

• Change in surface markers for monocyte activation

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

• Change in systemic inflammation

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

• Change in systemic inflammation measured indirectly

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

• Change in gene expression profile in whole blood

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

• Change in blood lipids

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

Study Arms (6)

Group 1

EXPERIMENTAL

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

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 2

EXPERIMENTAL

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

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 3

EXPERIMENTAL

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

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 4

EXPERIMENTAL

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

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 5

EXPERIMENTAL

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

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 6

EXPERIMENTAL

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

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

Interventions

High saturated fat meal, placebo powder and sunflower oil DIETARY_SUPPLEMENT

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

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

High saturated fat meal, blueberry powder and sunflower oil DIETARY_SUPPLEMENT

High saturated fat meal with blueberry powder shake and sunflower oil

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

High saturated fat meal, placebo powder and DHA DIETARY_SUPPLEMENT

High saturated fat meal with a blueberry flavored shake and DHA

Group 1; Group 2; Group 3; Group 4; Group 5; Group 6

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead
• University of California, Davis: collaborator

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (1)

• 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.

  PMID: 32040591 DERIVED

MeSH Terms

Conditions

Inflammation

Interventions

Sunflower Oil

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Oils; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Daniel Hwang, PhD

  USDA, ARS, Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 15, 2015
• Study Start: June 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: October 30, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)