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Inflammation, Polyphenols, and Genetics

Primary Purpose

Overweight, Obese

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Blackraspberry Slurry
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Overweight

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  • adult males over 55 years of age
  • overweight or obese

Exclusion Criteria:

  • 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

Sites / Locations

  • The Ohio State Univesity

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Blackraspberry slurry, washout, water

Water, washout, Blackraspberry slurry

Arm Description

Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days

8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days

Outcomes

Primary Outcome Measures

Serum IL-6
Area Under the time-concentration Curve (AUC) of IL-6

Secondary Outcome Measures

Full Information

First Posted
March 29, 2012
Last Updated
September 26, 2016
Sponsor
Ohio State University
Collaborators
Medical College of Wisconsin
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1. Study Identification

Unique Protocol Identification Number
NCT01568827
Brief Title
Inflammation, Polyphenols, and Genetics
Official Title
Inflammation, Polyphenols, and Genetics: A Pilot Study in Overweight and Obese Adult Males to Determine Whether Black-Raspberry Consumption Affects Markers of Inflammation in Study Participants Fed a High-Fat, High-Calorie Challenge Meal
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University
Collaborators
Medical College of Wisconsin

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
A high-fat, high-calorie challenge meal is administered to induce an inflammatory response in overweight and obese adult males. Serum levels of CRP, TNF-alpha, and IL-6 are measured prior to the challenge meal and at various times (1,2,4,8, and 12 hours) after the challenge meal. The challenge meal is given once without intervention and once after 5 daily doses of concentrated black-raspberry powder mixed in water.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight, Obese

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blackraspberry slurry, washout, water
Arm Type
Experimental
Arm Description
Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
Arm Title
Water, washout, Blackraspberry slurry
Arm Type
Experimental
Arm Description
8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Blackraspberry Slurry
Intervention Description
Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.
Primary Outcome Measure Information:
Title
Serum IL-6
Description
Area Under the time-concentration Curve (AUC) of IL-6
Time Frame
acute (0-12 hours) after inflammation-causing challenge meal

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adult males over 55 years of age overweight or obese Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph P Kitzmiller, MD PhD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State Univesity
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23982695
Citation
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.
Results Reference
result

Learn more about this trial

Inflammation, Polyphenols, and Genetics

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