Status:
TERMINATED
Tomato Juice for Health Study
Lead Sponsor:
USDA Beltsville Human Nutrition Research Center
Conditions:
Healthy Volunteers
Eligibility:
All Genders
30-75 years
Phase:
NA
Brief Summary
The primary objective of this study is to determine if tomato-soy juice can reduce inflammation, which is linked to chronic disease
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- Between 30 and 75 years old
- Voluntarily agree to participate and sign an informed consent document
Exclusion
- Aged \< 30 years or \> 75 years
- 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
Key Trial Info
Start Date :
January 8 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 25 2021
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT03783013
Start Date
January 8 2019
End Date
August 25 2021
Last Update
June 10 2022
Active Locations (1)
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1
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, United States, 20705