HealthyNCT02550483
Novel Metabolites of Beta-Carotene and Lycopene
A study testing Base diet + high beta-carotene tomato juice and Base diet + high lycopene tomato juice in people with Healthy, run by USDA Beltsville Human Nutrition Research Center at 1 site in United States.
Trial summary
The study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants will start with a 2-week free-living wash-in period where they will be asked to avoid certain carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Base diet + high beta-carotene tomato juice and Base diet + high lycopene tomato juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2015to Nov 2015
- 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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Age less than 21 or greater than 75 years
- Glucose > 126 mg/dl
- Triglycerides > 300 mg/dl
- Known allergy or intolerance to tomatoes or tomato products
- Pregnant, lactating, or intend to become pregnant during the study period
- History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
Show all 14Show fewer
- Smoker or use of tobacco products
- Presently have cancer
- Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
- Type 2 diabetes
- Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
- Unable or unwilling to give informed consent or communicate with study staff
- Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
- 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 Beltsville Human Nutrition Research Center
Beltsville, Maryland, 20705
About this study
The study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants will start with a 2-week free-living wash-in period where they will be asked to avoid certain carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. In addition to the controlled diet, participants will consume one of three beverages (300 mL/day; n = 12/group): placebo beverage (control), high beta-carotene tomato juice, and high-lycopene tomato juice. Blood, urine and feces will be collected throughout the study.
- Conditions
- Healthy
- Being tested
- Base diet + high beta-carotene tomato juice, Base diet + high lycopene tomato juice, Base diet + placebo beverage
- Keywords
- Healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Base diet + high beta-carotene tomato juiceOther
Participants will receive high beta-carotene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
Base diet + high lycopene tomato juiceOther
Participants will receive high lycopene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
Base diet + placebo beverageOther
Participants will receive a placebo beverage daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
| Study group | Role | What they receive |
|---|---|---|
| Beta-Carotene Tomato Juice | Active comparator | Participants will receive high beta-carotene tomato juice daily as part of controlled diet (base diet + high beta-carotene tomato juice). Receives: Other: Base diet + high beta-carotene tomato juice |
| Lycopene Tomato Juice | Active comparator | Participants will receive high lycopene tomato juice daily as part of controlled diet (base diet + high lycopene tomato juice). Receives: Other: Base diet + high lycopene tomato juice |
| Placebo Beverage | Placebo comparator | Participants will receive placebo beverage daily as part of controlled diet (base diet + placebo beverage). Receives: Other: Base diet + placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in apocarotenoid concentrations will be measured in blood
Apocarotenoid concentrations will be measured in blood (baseline, after washout; 2 wks; 4 wks).
Measured: Baseline, 2 weeks, 4 weeks
Change in carotenoid concentrations will be measured in blood
Carotenoid concentrations will be measured in blood (baseline, after washout; 2 wks, 4 wks).
Measured: Baseline, 2 weeks, 4 weeks
Secondary outcomes (3)
Change in global gene expression
Amounts of messenger RNA will be measured in blood samples to determine if the consumption of carotenoid-rich foods will affect gene expression of pathways related to cancer risk.
Measured: Baseline, 4 weeks
Change in proportion of phyla of colonic microbiota
Ribosomal RNA will be measured to determine relative amounts of different bacterial phyla present in the colon after consumption of the juice products differing in carotenoid concentration.
Measured: Baseline, 4 weeks
Identification of unknown urinary carotenoid metabolites
Identify previously unknown carotenoid metabolites in urine.
Measured: Baseline, 2 weeks, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionNov 2015
- Study completionNov 2015
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 HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 36 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
- NCT02550483
- Sponsor's protocol ID
- HS51
- Status last verified
- Apr 2018
- First submitted
- 8 Sep 2015
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Cooperstone JL, Novotny JA, Riedl KM, Cichon MJ, Francis DM, Curley RW Jr, Schwartz SJ, Harrison EH. Limited appearance of apocarotenoids is observed in plasma after consumption of tomato juices: a randomized human clinical trial. Am J Clin Nutr. 2018 Oct 1;108(4):784-792. doi: 10.1093/ajcn/nqy177.
PubMed 30239552
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Metabolites of Beta-Carotene and Lycopene
- ClinicalTrials.gov ID
- NCT02550483
- Acronym / sponsor ID
- HS51
- Conditions
- Healthy
- Keywords
- Healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- USDA Beltsville Human Nutrition Research CenterUS federal agency
- Study start
- Sep 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 15 Sep 2015 (estimated)
- 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 study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants will start with a 2-week free-living wash-in period where they will be asked to avoid certain carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. In addition to the controlled diet, participants will consume one of three beverages (300 mL/day; n = 12/group): placebo beverage (control), high beta-carotene tomato juice, and high-lycopene tomato juice. Blood, urine and feces will be collected throughout the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Beta-Carotene Tomato Juice | Active comparator | Other: Base diet + high beta-carotene tomato juiceParticipants will receive high beta-carotene tomato juice daily as part of controlled diet (base diet + high beta-carotene tomato juice). |
| Lycopene Tomato Juice | Active comparator | Other: Base diet + high lycopene tomato juiceParticipants will receive high lycopene tomato juice daily as part of controlled diet (base diet + high lycopene tomato juice). |
| Placebo Beverage | Placebo comparator | Other: Base diet + placebo beverageParticipants will receive placebo beverage daily as part of controlled diet (base diet + placebo beverage). |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (14 listed)
- Age less than 21 or greater than 75 years
- Glucose > 126 mg/dl
- Triglycerides > 300 mg/dl
- Known allergy or intolerance to tomatoes or tomato products
- Pregnant, lactating, or intend to become pregnant during the study period
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 |
|---|---|---|
| Base diet + high beta-carotene tomato juiceParticipants will receive high beta-carotene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda. | Other | Beta-Carotene Tomato Juice |
| Base diet + high lycopene tomato juiceParticipants will receive high lycopene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda. | Other | Lycopene Tomato Juice |
| Base diet + placebo beverageParticipants will receive a placebo beverage daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda. | Other | Placebo Beverage |
Primary outcome
Change in apocarotenoid concentrations will be measured in blood
Time frame: Baseline, 2 weeks, 4 weeks
Apocarotenoid concentrations will be measured in blood (baseline, after washout; 2 wks; 4 wks).
Change in carotenoid concentrations will be measured in blood
Time frame: Baseline, 2 weeks, 4 weeks
Carotenoid concentrations will be measured in blood (baseline, after washout; 2 wks, 4 wks).
3 secondary outcomes
Change in global gene expression
Time frame: Baseline, 4 weeks
Change in proportion of phyla of colonic microbiota
Time frame: Baseline, 4 weeks
Identification of unknown urinary carotenoid metabolites
Time frame: Baseline, 2 weeks, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Derived from this study: PubMed 30239552Cooperstone JL, Novotny JA, Riedl KM, Cichon MJ, Francis DM, Curley RW Jr, Schwartz SJ, Harrison EH. Limited appearance of apocarotenoids is observed in plasma after consumption of tomato juices: a randomized human clinical trial. Am J Clin Nutr. 2018 Oct 1;108(4):784-792. doi: 10.1093/ajcn/nqy177.
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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 Base diet + high beta-carotene tomato juice and Base diet + high lycopene tomato juice in people with Healthy, 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 0 inclusion and 14 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: finished, as of the sponsor's last update on 26 Apr 2018. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in apocarotenoid concentrations will be measured in blood (time frame: Baseline, 2 weeks, 4 weeks). The study lists 2 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 NCT02550483, 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 26 Apr 2018.