Tomato Juice for Health Study

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03783013
• Other study ID #: HS61 - Tomato Juice Study
• Status: Terminated
• Phase: N/A
• Start date: January 8, 2019
• Est. completion date: August 25, 2021

Study information

• Verified date: June 2022
• Source: USDA Beltsville Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: August 25, 2021
• Est. primary completion date: August 25, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• High Lycopene Tomato Juice With Soy Germ Extract
Tomato juice made from high lycopene tomatoes with soy germ extract added
• Low Lycopene Tomato Juice
Tomato juice made from low lycopene tomatoes with no soy germ extract added

Locations

Country	Name	City	State
United States	USDA-ARS Beltsville Human Nutrition Research Center	Beltsville	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
USDA Beltsville Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Blood total cholesterol	Total cholesterol will be measured in blood. Units will be mmol/L.	Day 1, 15, 43, 71, 99 of the study
Secondary	Blood LDL cholesterol	LDL cholesterol will be measured in blood. Units will be mmol/L.	Day 1, 15, 43, 71, 99 of the study
Secondary	Blood HDL cholesterol	HDL cholesterol will be measured in blood. Units will be mmol/L.	Day 1, 15, 43, 71, 99 of the study
Secondary	Blood triglycerides	Triglycerides will be measured in blood. Units will be mmol/L.	Day 1, 15, 43, 71, 99 of the study
Secondary	Blood glucose	Glucose will be measured in blood. Units will be mmol/L.	Day 1, 15, 43, 71, 99 of the study
Secondary	Blood insulin	Insulin will be measured in blood. Units will be mmol/L.	Day 1, 15, 43, 71, 99 of the study
Secondary	Blood pressure	Blood pressure will be measured. Units will be mm Hg.	Day 1, 15, 43, 71, 99 of the study
Secondary	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