Tomato Juice for Health Study

USDA Beltsville Human Nutrition Research Center19 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Healthy Volunteers

Interventions

High Lycopene Tomato Juice With Soy Germ ExtractOTHER

Tomato juice made from high lycopene tomatoes with soy germ extract added

Low Lycopene Tomato JuiceOTHER

Tomato juice made from low lycopene tomatoes with no soy germ extract added

Eligibility

Sex: ALLMin age: 30 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Outcomes

Primary Outcomes

Interleukin 6

Interleukin 6 (IL6) is a blood cytokine and an indicator of inflammatory status. IL6 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.

Time frame: Day 15 of the study

Interleukin 6

Time frame: Day 43 of the study

Interleukin 6

Time frame: Day 71 of the study

Interleukin 6

Time frame: Day 99 of the study

Interleukin 8

Interleukin 8 (IL8) is a blood cytokine and an indicator of inflammatory status. IL8 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.

Time frame: Day 15 of the study

Interleukin 8

Time frame: Day 43 of the study

Interleukin 8

Data from ClinicalTrials.gov

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Time frame: Day 71 of the study

Interleukin 8

Time frame: Day 99 of the study

Tumor Necrosis Factor Alpha

Tumor Necrosis Factor Alpha (TNF-a) is a blood cytokine and an indicator of inflammatory status. TNF-a will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.

Time frame: Day 15 of the study

Tumor Necrosis Factor Alpha

Time frame: Day 43 of the study

Tumor Necrosis Factor Alpha

Time frame: Day 71 of the study

Tumor Necrosis Factor Alpha

Time frame: Day 99 of the study

Monocyte chemoattractant protein-1

Monocyte chemoattractant protein-1 (MCP-1) is a signalling molecule and is part of the inflammatory process. MCP-1 will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.

Time frame: Day 15 of the study

Monocyte chemoattractant protein-1

Time frame: Day 43 of the study

Monocyte chemoattractant protein-1

Time frame: Day 71 of the study

Monocyte chemoattractant protein-1

Time frame: Day 99 of the study

Interferon Gamma

Interferon gamma (INF-g) is a signalling molecule and is part of the inflammatory process. INF-g will be measured to determine how the treatment is affecting inflammatory status. Cytokines are measured in units of pg/mL.

Time frame: Day 15 of the study

Interferon Gamma

Time frame: Day 43 of the study

Interferon Gamma

Time frame: Day 71 of the study

Interferon Gamma

Time frame: Day 99 of the study

Secondary Outcomes

Flavonoids/Isoflavones will be measured

Blood and Urine will be analyzed for flavonoids/isoflavones and their metabolites in units of nanomolar

Time frame: Days 1, 15, 43, 71, 99 of the study

Carotenoids will be measured

Blood will be analyzed for carotenoids and metabolites in units of mmolar

Time frame: Days 1, 15, 43, 71, 99 of the study

Identification of metabolites that change in blood and urine by metabolomics

Metabolomics is the simultaneous measurement of the many thousand small molecule metabolites. Chromatography separates the metabolites, which are then ionized, then the detector detects the number of ion hits for each ion, which reflects the amount (number of ions) of a particular compound. If the detector detects more of an ion in blood or urine after one treatment vs. another, then the position on the chromatogram (units of time in minutes) and the ratio of the mass (atomic mass units) to charge (unitless) of the compound will be compared to the 75,000 entries in the METLIN metabolite library to identify what the compound is.

Time frame: Days 1, 15, 43, 71, 99 of the study

Cytokine production by peripheral blood mononuclear cells

Peripheral blood mononuclear cells produce inflammation molecules called cytokines when exposed to an irritant (called the stimulant in the assay). Peripheral blood mononuclear cells will be stimulated with an irritant and cytokine production will be measured in units of pg/ml.