Inflammation, Polyphenols, and Genetics

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-05-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Overweight Obese

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Blackraspberry slurry, washout, water

Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days

Group Type EXPERIMENTAL

Blackraspberry Slurry

Intervention Type DIETARY_SUPPLEMENT

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

Water, washout, Blackraspberry slurry

8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days

Group Type EXPERIMENTAL

Blackraspberry Slurry

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Blackraspberry Slurry

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes