Tomato Juice for Health Study

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

Detailed Description
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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.

Official Title
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The Influence of Tomato Soy Juice on Inflammation in Overweight and Obese Adults

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: High Lycopene Tomato Juice With Soy Germ Extract
* Other: Low Lycopene Tomato Juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: No Soy and Low Lycopene Juice<br>Participants will consume two cans daily of a low lycopene tomato juice in addition to a diet low in lycopene and isoflavones. | Other: Low Lycopene Tomato Juice<br>* Tomato juice made from low lycopene tomatoes with no soy germ extract added<br>|
| Other: Soy and Lycopene Juice<br>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. | Other: High Lycopene Tomato Juice With Soy Germ Extract<br>* Tomato juice made from high lycopene tomatoes with soy germ extract added<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Day 15 of the study | 
| 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. | Day 43 of the study | 
| 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. | Day 71 of the study | 
| 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. | 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. | Day 15 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. | Day 43 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. | Day 71 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. | 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. | Day 15 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. | Day 43 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. | Day 71 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. | 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. | Day 15 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. | Day 43 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. | Day 71 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. | 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. | Day 15 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. | Day 43 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. | Day 71 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. | Day 99 of the study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flavonoids/Isoflavones will be measured | Blood and Urine will be analyzed for flavonoids/isoflavones and their metabolites in units of nanomolar | 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 | 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. | 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. | Day 1, 15, 43, 71, 99 of the study | 
| Blood total cholesterol | Total cholesterol will be measured in blood. Units will be mmol/L. | Day 1, 15, 43, 71, 99 of the study | 
| Blood LDL cholesterol | LDL cholesterol will be measured in blood. Units will be mmol/L. | Day 1, 15, 43, 71, 99 of the study | 
| Blood HDL cholesterol | HDL cholesterol will be measured in blood. Units will be mmol/L. | Day 1, 15, 43, 71, 99 of the study | 
| Blood triglycerides | Triglycerides will be measured in blood. Units will be mmol/L. | Day 1, 15, 43, 71, 99 of the study | 
| Blood glucose | Glucose will be measured in blood. Units will be mmol/L. | Day 1, 15, 43, 71, 99 of the study | 
| Blood insulin | Insulin will be measured in blood. Units will be mmol/L. | Day 1, 15, 43, 71, 99 of the study | 
| Blood pressure | Blood pressure will be measured. Units will be mm Hg. | Day 1, 15, 43, 71, 99 of the study | 
| High Sensitivity c-Reactive Protein | High sensitivity c-reactive protein will be measured in blood. Units will be mg/dL. | Day 1, 15, 43, 71, 99 of the study |