Healthy VolunteersNCT03783013
Tomato Juice for Health Study
A study testing High Lycopene Tomato Juice With Soy Germ Extract and Low Lycopene Tomato Juice in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
The primary objective of this study is to determine if tomato-soy juice can reduce inflammation, which is linked to chronic disease Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- High Lycopene Tomato Juice With Soy Germ Extract and Low Lycopene Tomato Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2019to 25 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between 30 and 75 years old
- Voluntarily agree to participate and sign an informed consent document
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
USDA-ARS Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
Official title: The Influence of Tomato Soy Juice on Inflammation in Overweight and Obese Adults
The primary objective of this study is to determine if tomato-soy juice can reduce inflammation, which is linked to chronic disease
Read the 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
- Being tested
- High Lycopene Tomato Juice With Soy Germ Extract, Low Lycopene Tomato Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Lycopene Tomato Juice With Soy Germ ExtractOther
Tomato juice made from high lycopene tomatoes with soy germ extract added
Low Lycopene Tomato JuiceOther
Tomato juice made from low lycopene tomatoes with no soy germ extract added
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: High Lycopene Tomato Juice With Soy Germ Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 99 of the study
Secondary outcomes (12)
Flavonoids/Isoflavones will be measured
Blood and Urine will be analyzed for flavonoids/isoflavones and their metabolites in units of nanomolar
Measured: Days 1, 15, 43, 71, 99 of the study
Carotenoids will be measured
Blood will be analyzed for carotenoids and metabolites in units of mmolar
Measured: Days 1, 15, 43, 71, 99 of the study
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.
Measured: Days 1, 15, 43, 71, 99 of the study
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.
Measured: Day 1, 15, 43, 71, 99 of the study
Blood total cholesterol
Total cholesterol will be measured in blood. Units will be mmol/L.
Measured: Day 1, 15, 43, 71, 99 of the study
Blood LDL cholesterol
LDL cholesterol will be measured in blood. Units will be mmol/L.
Measured: Day 1, 15, 43, 71, 99 of the study
Blood HDL cholesterol
HDL cholesterol will be measured in blood. Units will be mmol/L.
Measured: Day 1, 15, 43, 71, 99 of the study
Blood triglycerides
Triglycerides will be measured in blood. Units will be mmol/L.
Measured: Day 1, 15, 43, 71, 99 of the study
Blood glucose
Glucose will be measured in blood. Units will be mmol/L.
Measured: Day 1, 15, 43, 71, 99 of the study
Blood insulin
Insulin will be measured in blood. Units will be mmol/L.
Measured: Day 1, 15, 43, 71, 99 of the study
Blood pressure
Blood pressure will be measured. Units will be mm Hg.
Measured: Day 1, 15, 43, 71, 99 of the study
High Sensitivity c-Reactive Protein
High sensitivity c-reactive protein will be measured in blood. Units will be mg/dL.
Measured: Day 1, 15, 43, 71, 99 of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2018
- Study start8 Jan 2019
- Primary completion25 Aug 2021
- Study completion25 Aug 2021
Why it stopped: This study was halted prematurely because of research restrictions related to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA Beltsville Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Janet Novotny, USDA Beltsville Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03783013
- Sponsor's protocol ID
- HS61 - Tomato Juice Study
- Status last verified
- Jun 2022
- First submitted
- 18 Dec 2018
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sholola MJ, Miller J, Bilbrey EA, Novotny JA, Francis DM, Mace TA, Cooperstone JL. Tomato-Soy Juice Reduces Inflammation and Modulates the Urinary Metabolome in Adults With Obesity. Mol Nutr Food Res. 2026 Mar;70(5):e70420. doi: 10.1002/mnfr.70420.
PubMed 41787829
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Tomato Soy Juice on Inflammation in Overweight and Obese Adults
- ClinicalTrials.gov ID
- NCT03783013
- Acronym / sponsor ID
- HS61 - Tomato Juice Study
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was halted prematurely because of research restrictions related to COVID-19
- Enrolment
- 19 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- 8 Jan 2019 (actual)
- Primary completion
- 25 Aug 2021 (actual)
- Study completion
- 25 Aug 2021 (actual)
- First posted
- 20 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No Soy and Low Lycopene Juice | Other | Other: Low Lycopene Tomato JuiceParticipants will consume two cans daily of a low lycopene tomato juice in addition to a diet low in lycopene and isoflavones. |
| Soy and Lycopene Juice | Other | Other: High Lycopene Tomato Juice With Soy Germ ExtractParticipants 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. |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Between 30 and 75 years old
- Voluntarily agree to participate and sign an informed consent document
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Lycopene Tomato Juice With Soy Germ ExtractTomato juice made from high lycopene tomatoes with soy germ extract added | Other | Soy and Lycopene Juice |
| Low Lycopene Tomato JuiceTomato juice made from low lycopene tomatoes with no soy germ extract added | Other | No Soy and Low Lycopene Juice |
Primary outcome
Interleukin 6
Time frame: 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 6
Time frame: Day 43 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 6
Time frame: Day 71 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 6
Time frame: Day 99 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
Time frame: 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.
Interleukin 8
Time frame: Day 43 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.
Interleukin 8
Time frame: Day 71 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.
Interleukin 8
Time frame: Day 99 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
Time frame: 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.
Tumor Necrosis Factor Alpha
Time frame: Day 43 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.
Tumor Necrosis Factor Alpha
Time frame: Day 71 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.
Tumor Necrosis Factor Alpha
Time frame: Day 99 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
Time frame: 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.
Monocyte chemoattractant protein-1
Time frame: Day 43 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.
Monocyte chemoattractant protein-1
Time frame: Day 71 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.
Monocyte chemoattractant protein-1
Time frame: Day 99 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
Time frame: 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.
Interferon Gamma
Time frame: Day 43 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.
Interferon Gamma
Time frame: Day 71 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.
Interferon Gamma
Time frame: Day 99 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.
12 secondary outcomes
Flavonoids/Isoflavones will be measured
Time frame: Days 1, 15, 43, 71, 99 of the study
Carotenoids will be measured
Time frame: Days 1, 15, 43, 71, 99 of the study
Identification of metabolites that change in blood and urine by metabolomics
Time frame: Days 1, 15, 43, 71, 99 of the study
Cytokine production by peripheral blood mononuclear cells
Time frame: Day 1, 15, 43, 71, 99 of the study
Blood total cholesterol
Time frame: Day 1, 15, 43, 71, 99 of the study
Blood LDL cholesterol
Time frame: Day 1, 15, 43, 71, 99 of the study
Blood HDL cholesterol
Time frame: Day 1, 15, 43, 71, 99 of the study
Blood triglycerides
Time frame: Day 1, 15, 43, 71, 99 of the study
Blood glucose
Time frame: Day 1, 15, 43, 71, 99 of the study
Blood insulin
Time frame: Day 1, 15, 43, 71, 99 of the study
Blood pressure
Time frame: Day 1, 15, 43, 71, 99 of the study
High Sensitivity c-Reactive Protein
Time frame: Day 1, 15, 43, 71, 99 of the study
Results and safety
The study was stopped early (reason given: This study was halted prematurely because of research restrictions related to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
- Derived from this study: PubMed 41787829Sholola MJ, Miller J, Bilbrey EA, Novotny JA, Francis DM, Mace TA, Cooperstone JL. Tomato-Soy Juice Reduces Inflammation and Modulates the Urinary Metabolome in Adults With Obesity. Mol Nutr Food Res. 2026 Mar;70(5):e70420. doi: 10.1002/mnfr.70420.
- Individual participant dataSharing planned: No
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
RecruitingEarly Phase 1
Study Brain Mechanisms of Frustration With Magnetoencephalography in Healthy Volunteers
Irritability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Lycopene Tomato Juice With Soy Germ Extract and Low Lycopene Tomato Juice in people with Healthy Volunteers, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was halted prematurely because of research restrictions related to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interleukin 6 (time frame: Day 15 of the study). The study lists 20 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03783013, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.