Inflammation, Polyphenols, and Genetics

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

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.

Study Overview

• Status: Completed
• Conditions: Overweight; Obese
• Intervention / Treatment: Dietary supplement: Blackraspberry Slurry

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.

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State Univesity

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum IL-6	Area Under the time-concentration Curve (AUC) of IL-6	acute (0-12 hours) after inflammation-causing challenge meal

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: Medical College of Wisconsin
• Investigators: Principal Investigator: Joseph P Kitzmiller, MD PhD, Ohio State University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (Actual): May 1, 2012
• Study Completion (Actual): May 1, 2012

Study Registration Dates

• First Submitted: March 29, 2012
• First Submitted That Met QC Criteria: March 29, 2012
• First Posted (Estimate): April 2, 2012

Study Record Updates

• Last Update Posted (Estimate): September 27, 2016
• Last Update Submitted That Met QC Criteria: September 26, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Body Weight; Inflammation; Overweight
• Other Study ID Numbers: OSU 2011H0394

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No