Tomato Soy Juice for Men's Health



Status:Recruiting
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:30 - 60
Updated:3/6/2019
Start Date:April 1, 2019
End Date:August 30, 2019
Contact:Janet A Novotny, PhD
Email:janet.novotny@ars.usda.gov
Phone:301-504-8263

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The Influence of Tomato Soy Juice on Inflammation in Overweight and Obese Men

The primary objective of this study is to determine if tomato-soy juice can reduce
inflammation, which is linked to prostate cancer, in obese males.

The aim of this study is to improve understanding of how diet can ameliorate the state of
chronic inflammation. Short term inflammation is an important part of the body's response to
injury, but long term inflammation, as happens in the state of obesity, can result in a
multitude of secondary problems, like cancer, diabetes, and cardiovascular disease. In males,
chronic inflammation is linked to increased risk of prostate cancer. However, men who consume
high intakes of tomato or soy products have lower risk of prostate cancer, which may be
linked to reduction of chronic inflammation. Using a novel tomato-soy juice, we aim to
demonstrate the potential of tomato-soy juice for reducing inflammation in obese adult males.

Inclusion Criteria:

- Male

- Between 30 and 60 years old

- Voluntarily agree to participate and sign an informed consent document

Exclusion Criteria:

- Aged < 30 years or > 60 years

- Female

- Known allergy or intolerance to tomatoes or soy

- BMI < 30 or > 45 kg/m2

- Blood plasma glucose > 125 mg/dL

- Blood plasma/serum triglycerides > 250 mg/dL

- Blood plasma/serum cholesterol > 240 mg/dL

- Diabetes requiring the use of diabetes pills, insulin, or non-insulin shots

- Previous bariatric or gastrointestinal surgery affecting absorption

- Suspected or known strictures, fistulas or physiological/mechanical gastrointestinal
obstruction

- Presence of gastrointestinal or malabsorptive disorders (including Crohn's, ileus or
ulcerative colitis, or diverticulitis), or nutrient malabsorption disease (such as
celiac disease)

- Presence of autoimmune disease, metabolic disease, liver disorders, or kidney
disorders

- Diagnosis or treatment of certain cancers in the past 3 years

- Use of tobacco products or marijuana

- Daily use of anti-inflammatory drugs

- Use of antibiotics over the previous 3 months

- Colonoscopy within a month of the study start date or during the study

- Use of a carotenoid or isoflavone-containing or metabolism-altering supplement for the
last 1 month

- Use of certain medications (prescription or over-the-counter) that may interfere with
the study objectives

- Unable or unwilling to give informed consent or communicate with study staff

- Other medical, psychiatric, or behavioral factors that in the judgment of the
Principal Investigator may interfere with study participation or the ability to follow
the intervention protocol
We found this trial at
1
site
Beltsville, Maryland 20705
Principal Investigator: Janet A Novotny, Ph.D.
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mi
from
Beltsville, MD
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