Tomato Juice for Health Study

Beltsville Human Nutrition Research Center (BHNRC)

Status: Terminated

Conditions: Healthy Volunteers

Treatments: Other: Low Lycopene Tomato Juice; Other: High Lycopene Tomato Juice With Soy Germ Extract

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT03783013

HS61 - Tomato Juice Study

Details and patient eligibility

About

The primary objective of this study is to determine if tomato-soy juice can reduce inflammation, which is linked to chronic disease

Full 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 term inflammation, as happens in the state of obesity, can result in a multitude of secondary problems, like cancer, diabetes, and cardiovascular disease. Using a novel tomato-soy juice, we aim to demonstrate the potential of tomato-soy juice for reducing inflammation in adults.

Enrollment: 19 patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Between 30 and 75 years old
• Voluntarily agree to participate and sign an informed consent document

Exclusion criteria

• 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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19 participants in 2 patient groups

No Soy and Low Lycopene Juice

Other group

Description:

Participants will consume two cans daily of a low lycopene tomato juice in addition to a diet low in lycopene and isoflavones.

Treatment:

Other: Low Lycopene Tomato Juice

Soy and Lycopene Juice

Other group

Description:

Participants will consume two cans daily of a high lycopene tomato juice with added soy germ extract in addition to a diet low in lycopene and isoflavones.

Treatment:

Other: High Lycopene Tomato Juice With Soy Germ Extract