NCT03783013

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Jan 2019

Longer than P75 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 18, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
19 days until next milestone

Study Start

First participant enrolled

January 8, 2019

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2021

Completed
Last Updated

June 10, 2022

Status Verified

June 1, 2022

Enrollment Period

2.6 years

First QC Date

December 18, 2018

Last Update Submit

June 7, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (20)

  • 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 Outcomes (12)

  • Flavonoids/Isoflavones will be measured

    Days 1, 15, 43, 71, 99 of the study

  • Carotenoids will be measured

    Days 1, 15, 43, 71, 99 of the study

  • Identification of metabolites that change in blood and urine by metabolomics

    Days 1, 15, 43, 71, 99 of the study

  • Cytokine production by peripheral blood mononuclear cells

    Day 1, 15, 43, 71, 99 of the study

  • Blood total cholesterol

    Day 1, 15, 43, 71, 99 of the study

  • +7 more secondary outcomes

Study Arms (2)

No Soy and Low Lycopene Juice

OTHER

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

Soy and Lycopene Juice

OTHER

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

Interventions

High Lycopene Tomato Juice With Soy Germ ExtractOTHER

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

Soy and Lycopene Juice
Low Lycopene Tomato JuiceOTHER

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

No Soy and Low Lycopene Juice

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Between 30 and 75 years old
  • Voluntarily agree to participate and sign an informed consent document

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

USDA-ARS Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Physiologist

Study Record Dates

First Submitted

December 18, 2018

First Posted

December 20, 2018

Study Start

January 8, 2019

Primary Completion

August 25, 2021

Study Completion

August 25, 2021

Last Updated

June 10, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)