NCT01594008

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 4, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 8, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

March 24, 2015

Status Verified

May 1, 2013

Enrollment Period

1.3 years

First QC Date

May 4, 2012

Last Update Submit

March 20, 2015

Conditions

Inflammation

Keywords

Toll like receptorsInflammationAnthocyaninsBlueberries

Outcome Measures

Primary Outcomes (1)

  • Monocyte activation in whole blood

    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 Outcomes (1)

  • Peripheral blood mononuclear (PBMC) activation

    Change from 0 to 3.5 hours

Interventions

Breakfast meal with placebo powderOTHER

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.

Breakfast meal with 2 serving equivalents of blueberriesOTHER

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.

Breakfast meal with 4 serving equivalents of blueberriesOTHER

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults
  • Able to complete study procedures
  • Body Mass Index 18 - 24.9 kg/m2

You may not qualify if:

  • 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
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA, ARS, Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

Related Publications (1)

  • 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.

    PMID: 27306892DERIVED

Related Links

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Daniel Hwang, PhD

    USDA, ARS, Western Human Nutrition Research Center

    PRINCIPAL INVESTIGATOR

  • John Rutledge, MD

    University of California, Davis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2012

First Posted

May 8, 2012

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

March 24, 2015

Record last verified: 2013-05

Locations

US(1)