Inflammation, Polyphenols, and Genetics

Overweight Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01568827
• Other study ID #: OSU 2011H0394
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 29, 2012
• Last updated: September 26, 2016
• Start date: March 2012
• Est. completion date: May 2012

Study information

• Verified date: September 2016
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 55 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Inflammation
• Obese
• Overweight

Intervention

Dietary Supplement:
• Blackraspberry Slurry
Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.

Locations

Country	Name	City	State
United States	The Ohio State Univesity	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

References & 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):e8 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum IL-6	Area Under the time-concentration Curve (AUC) of IL-6	acute (0-12 hours) after inflammation-causing challenge meal	No