Clinical trial NCT03783013: Tomato Juice for Health Study
Official title: The Influence of Tomato Soy Juice on Inflammation in Overweight and Obese Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy Volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2018-12-20
Enrollment: 19
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Interleukin 6
timeFrame: Day 15 of the study
measure: Interleukin 6
timeFrame: Day 43 of the study
measure: Interleukin 6
timeFrame: Day 71 of the study
measure: Interleukin 6
timeFrame: Day 99 of the study
measure: Interleukin 8
timeFrame: Day 15 of the study
measure: Interleukin 8
timeFrame: Day 43 of the study
measure: Interleukin 8
timeFrame: Day 71 of the study
measure: Interleukin 8
timeFrame: Day 99 of the study
measure: Tumor Necrosis Factor Alpha
timeFrame: Day 15 of the study
measure: Tumor Necrosis Factor Alpha
timeFrame: Day 43 of the study
measure: Tumor Necrosis Factor Alpha
timeFrame: Day 71 of the study
measure: Tumor Necrosis Factor Alpha
timeFrame: Day 99 of the study
measure: Monocyte chemoattractant protein-1
timeFrame: Day 15 of the study
measure: Monocyte chemoattractant protein-1
timeFrame: Day 43 of the study
measure: Monocyte chemoattractant protein-1
timeFrame: Day 71 of the study
measure: Monocyte chemoattractant protein-1
timeFrame: Day 99 of the study
measure: Interferon Gamma
timeFrame: Day 15 of the study
measure: Interferon Gamma
timeFrame: Day 43 of the study
measure: Interferon Gamma
timeFrame: Day 71 of the study
measure: Interferon Gamma
timeFrame: Day 99 of the study
Secondary outcomes:
measure: Flavonoids/Isoflavones will be measured
timeFrame: Days 1, 15, 43, 71, 99 of the study
measure: Carotenoids will be measured
timeFrame: Days 1, 15, 43, 71, 99 of the study
measure: Identification of metabolites that change in blood and urine by metabolomics
timeFrame: Days 1, 15, 43, 71, 99 of the study
measure: Cytokine production by peripheral blood mononuclear cells
timeFrame: Day 1, 15, 43, 71, 99 of the study
measure: Blood total cholesterol
timeFrame: Day 1, 15, 43, 71, 99 of the study
measure: Blood LDL cholesterol
timeFrame: Day 1, 15, 43, 71, 99 of the study
measure: Blood HDL cholesterol
timeFrame: Day 1, 15, 43, 71, 99 of the study
measure: Blood triglycerides
timeFrame: Day 1, 15, 43, 71, 99 of the study
measure: Blood glucose
timeFrame: Day 1, 15, 43, 71, 99 of the study
measure: Blood insulin
timeFrame: Day 1, 15, 43, 71, 99 of the study
measure: Blood pressure
timeFrame: Day 1, 15, 43, 71, 99 of the study
measure: High Sensitivity c-Reactive Protein
timeFrame: Day 1, 15, 43, 71, 99 of the study
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA-ARS Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References: