Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Beltsville, Maryland 20705


Purpose:

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.


Study summary:

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.


Criteria:

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


NCT ID:

NCT03783013


Primary Contact:

Janet A Novotny, PhD
Phone: 301-504-8263
Email: janet.novotny@ars.usda.gov


Backup Contact:

N/A


Location Contact:

Beltsville, Maryland 20705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.