Inflammation, Polyphenols, and Genetics

This study has been completed.
Sponsor:
Collaborator:
Medical College of Wisconsin
Information provided by (Responsible Party):
Joseph Kitzmiller, Ohio State University
ClinicalTrials.gov Identifier:
NCT01568827
First received: March 29, 2012
Last updated: February 17, 2016
Last verified: February 2016
  Purpose
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.

Condition Intervention Phase
Overweight
Obese
Dietary Supplement: Blackraspberry Slurry
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Further study details as provided by Ohio State University:

Primary Outcome Measures:
  • Serum IL-6 [ Time Frame: acute (0-12 hours) after inflammation-causing challenge meal ] [ Designated as safety issue: No ]
    Area Under the time-concentration Curve (AUC) of IL-6


Enrollment: 10
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Blackraspberry slurry, washout, water
Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
Dietary Supplement: Blackraspberry Slurry
Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.
Experimental: Water, washout, Blackraspberry slurry
8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
Dietary Supplement: Blackraspberry Slurry
Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.

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.
  Eligibility

Ages Eligible for Study:   55 Years and older   (Adult, Senior)
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01568827

Locations
United States, Ohio
The Ohio State Univesity
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University
Medical College of Wisconsin
Investigators
Principal Investigator: Joseph P Kitzmiller, MD PhD Ohio State University
  More Information

Publications:
Responsible Party: Joseph Kitzmiller, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT01568827     History of Changes
Other Study ID Numbers: OSU 2011H0394 
Study First Received: March 29, 2012
Results First Received: September 25, 2015
Last Updated: February 17, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Additional relevant MeSH terms:
Inflammation
Overweight
Pathologic Processes
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 29, 2016