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OpenTrials
Completed

NCT Number: NCT01568827

Inflammation, Polyphenols, and Genetics

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obese Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

55 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Ohio State Univesity

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blackraspberry Slurry

Dietary Supplement

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

Primary outcomes

  1. Serum IL-6

    Time frame: acute (0-12 hours) after inflammation-causing challenge meal

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

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Medical College of Wisconsin

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 2, 2012
Registry last updated
Sep 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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