Inflammation, Polyphenols, and Genetics
1 other identifier
interventional
10
1 country
1
Brief Summary
Pilot study to determine whether daily consumption of blackraspberry powder (high in polyphenols) can reduce markers of inflammation and to determine whether genetics influence baseline levels of inflammatory markers as well as individual's response to polyphenols. A total of 10 males participated in this cross-over study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Mar 2012
Shorter than P25 for phase_1
1 active site
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
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 29, 2012
CompletedFirst Posted
Study publicly available on registry
April 2, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedResults Posted
Study results publicly available
March 15, 2016
CompletedSeptember 27, 2016
September 1, 2016
2 months
March 29, 2012
September 25, 2015
September 26, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Serum IL-6
Area Under the time-concentration Curve (AUC) of IL-6
acute (0-12 hours) after inflammation-causing challenge meal
Study Arms (2)
Blackraspberry slurry, washout, water
EXPERIMENTALBlackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
Water, washout, Blackraspberry slurry
EXPERIMENTAL8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
Interventions
Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.
Eligibility Criteria
You may qualify if:
- adult males over 55 years of age
- overweight or obese
You may not qualify if:
- history of adverse reaction to berries or berry products
- history of adverse reaction to high-fat, high-calorie challenge meal
- significant liver or renal insufficiency
- significant cognitive impairment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ohio State Universitylead
- Medical College of Wisconsincollaborator
Study Sites (1)
The Ohio State Univesity
Columbus, Ohio, 43210, United States
Related Publications (1)
Sardo CL, Kitzmiller JP, Apseloff G, Harris RB, Roe DJ, Stoner GD, Jacobs ET. An Open-Label Randomized Crossover Trial of Lyophilized Black Raspberries on Postprandial Inflammation in Older Overweight Males: A Pilot Study. Am J Ther. 2016 Jan-Feb;23(1):e86-91. doi: 10.1097/MJT.0b013e3182a40bf8.
PMID: 23982695RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Joseph Kitzmiller
- Organization
- The Ohio State University
Study Officials
- PRINCIPAL INVESTIGATOR
Joseph P Kitzmiller, MD PhD
Ohio State University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
March 29, 2012
First Posted
April 2, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
September 27, 2016
Results First Posted
March 15, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will not share