Tomato Juice for Health Study

NCT ID: NCT03783013

Last Updated: 2022-06-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-08
• Study Completion Date: 2021-08-25

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.

Conditions

Healthy Volunteers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

No Soy and Low Lycopene Juice

Participants will consume two cans daily of a low lycopene tomato juice in addition to a diet low in lycopene and isoflavones.

Group Type: OTHER

Low Lycopene Tomato Juice

Intervention Type: OTHER

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

Soy and Lycopene Juice

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.

Group Type: OTHER

High Lycopene Tomato Juice With Soy Germ Extract

Intervention Type: OTHER

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

Interventions

High Lycopene Tomato Juice With Soy Germ Extract

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

Intervention Type: OTHER

Low Lycopene Tomato Juice

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Janet Novotny

Research Physiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

Other Identifiers

HS61 - Tomato Juice Study

Identifier Type: -

Identifier Source: org_study_id