Inflammation, Polyphenols, and Genetics

Phase 1

Completed

• Conditions: Overweight; Obese
• Interventions: Dietary Supplement: Blackraspberry Slurry

• Registration Number: NCT01568827
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-03-29
• Study First Submitted QC: 2012-03-29
• Study First Posted: 2012-04-02
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2015-09-25
• Results First Submitted QC: 2016-02-17
• Results First Posted: 2016-03-15
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Blackraspberry slurry, washout, water	Blackraspberry Slurry	Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
Water, washout, Blackraspberry slurry	Blackraspberry Slurry	8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days

Primary Outcome Measures

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

Trial Locations

Locations (1)

The Ohio State Univesity; 🇺🇸 Columbus, Ohio, United States