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Inflammation, Polyphenols, and Genetics

The Ohio State University logo

The Ohio State University

Status and phase

Completed
Phase 2
Phase 1

Conditions

Obese
Overweight

Treatments

Dietary Supplement: Blackraspberry Slurry

Study type

Interventional

Funder types

Other

Identifiers

NCT01568827
OSU 2011H0394

Details and patient eligibility

About

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.

Full 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.

Enrollment

10 patients

Sex

Male

Ages

55+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

10 participants in 2 patient groups

Blackraspberry slurry, washout, water
Experimental group
Description:
Blackraspberry slurry daily x 5 days, 2 day washout, 8 oz. water daily x 5 days
Treatment:
Dietary Supplement: Blackraspberry Slurry
Water, washout, Blackraspberry slurry
Experimental group
Description:
8 oz. water daily x 5 days, 2 day washout, Blackraspberry slurry daily x 5 days
Treatment:
Dietary Supplement: Blackraspberry Slurry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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