Healthy Volunteers
Conditions
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 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.
Interventions
OTHERHigh Lycopene Tomato Juice With Soy Germ Extract
Tomato juice made from high lycopene tomatoes with soy germ extract added
OTHERLow Lycopene Tomato Juice
Tomato juice made from low lycopene tomatoes with no soy germ extract added
Sponsors
USDA Beltsville Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interleukin 6 | Day 15 of the study | 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. |
| Interleukin 8 | Day 15 of the study | 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. |
| Tumor Necrosis Factor Alpha | Day 15 of the study | 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. |
| Monocyte chemoattractant protein-1 | Day 15 of the study | 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. |
| Interferon Gamma | Day 15 of the study | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood LDL cholesterol | Day 1, 15, 43, 71, 99 of the study | LDL cholesterol will be measured in blood. Units will be mmol/L. |
| Blood HDL cholesterol | Day 1, 15, 43, 71, 99 of the study | HDL cholesterol will be measured in blood. Units will be mmol/L. |
| Blood triglycerides | Day 1, 15, 43, 71, 99 of the study | Triglycerides will be measured in blood. Units will be mmol/L. |
| Flavonoids/Isoflavones will be measured | Days 1, 15, 43, 71, 99 of the study | Blood and Urine will be analyzed for flavonoids/isoflavones and their metabolites in units of nanomolar |
| Blood insulin | Day 1, 15, 43, 71, 99 of the study | Insulin will be measured in blood. Units will be mmol/L. |
| Blood pressure | Day 1, 15, 43, 71, 99 of the study | Blood pressure will be measured. Units will be mm Hg. |
| High Sensitivity c-Reactive Protein | Day 1, 15, 43, 71, 99 of the study | High sensitivity c-reactive protein will be measured in blood. Units will be mg/dL. |
| Blood glucose | Day 1, 15, 43, 71, 99 of the study | Glucose will be measured in blood. Units will be mmol/L. |
| Carotenoids will be measured | Days 1, 15, 43, 71, 99 of the study | Blood will be analyzed for carotenoids and metabolites in units of mmolar |
| Identification of metabolites that change in blood and urine by metabolomics | Days 1, 15, 43, 71, 99 of the study | 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. |
| Cytokine production by peripheral blood mononuclear cells | Day 1, 15, 43, 71, 99 of the study | 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. |
| Blood total cholesterol | Day 1, 15, 43, 71, 99 of the study | Total cholesterol will be measured in blood. Units will be mmol/L. |
Countries
United States
Outcome results
None listed