HealthyNCT05319548
Plant Pigments for Human Health: Impact of Lycopene and Anthocyanins on Bioefficacy of Provitamin A Carotenoids From Carrots
A study testing Purple-Red Carrot Juice, Red Carrot Juice and Purple Carrot Juice in people with Healthy, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The proposed research will help characterize the impact that simultaneous consumption of anthocyanins and carotenoids has on the bioavailability of the provitamin A carotenoids a-carotene and b-carotene and the non-provitamin A carotenoid lycopene, and on their respective antidiabetic activity in humans. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Purple-Red Carrot Juice, Red Carrot Juice and Purple Carrot Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 11 May 2023
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Non-smoking
- Not pregnant (or planning to become pregnant)
- Body Mass Index (BMI) greater than 18.5 and less than 30
Who cannot join
- Major comorbidities (cardiovascular disease (CVD), diabetes, cancer, kidney/liver/bowel disease)
- History of malabsorptive/GI disorders
- Abnormal diet
- BMI less than 18.5 or greater than 30
- Food intolerances/allergies/hypersensitivities
- History of substance abuse or alcoholism
Show all 9Show fewer
- Unwilling to restrict consumption of specific foods prior to study
- Unwilling to participate in blood draws
- History of difficulty drawing blood/health issues associated with blood draws (gets dizzy, etc).
Trial locations and contacts
1 site in 1 country.
United States1 site
UW-Madison Department of Nutritional Sciences
Madison, Wisconsin, 53706
About this study
Official title: Plant Pigments for Human Health: Determining the Interactions the Impact of Co-ingestion of Carotenoids and Anthocyanins From Multicolored Carrots on the Bioavailability of Provitamin A Carotenoids and the Impact on Each Pigment Groups' Respective Antidiabetic Activity in Humans
The proposed research will help characterize the impact that simultaneous consumption of anthocyanins and carotenoids has on the bioavailability of the provitamin A carotenoids a-carotene and b-carotene and the non-provitamin A carotenoid lycopene, and on their respective antidiabetic activity in humans. The central hypothesis is that provitamin A carotenoids will be bioavailable from purple-red multicolored carrots in humans, and the co-ingestion of carotenoids and anthocyanins from these carrots will have synergistic impacts on their respective antioxidant and antidiabetic effects. This hypothesis will be assessed through a 53 day randomized crossover time course study that consists of three arms in which healthy males and females ages 18-40 (n = 12) will consume carrot juice prepared from red, purple-red, or purple carrots. During each arm, participants will switch the type of juice they consume and by the end of the third arm, all participants will have ingested juice made from all three carrot varieties. Blood will be collected at multiple time points over 72 hours following consumption.
- Conditions
- Healthy
- Being tested
- Purple-Red Carrot Juice, Red Carrot Juice, Purple Carrot Juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purple-Red Carrot JuiceOther
Purple-Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), the non-provitamin A carotenoid, lycopene, as well as anthocyanins
Red Carrot JuiceOther
Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), and the non-provitamin A carotenoid, lycopene, but does NOT contain anthocyanins..
Purple Carrot JuiceOther
Purple carrot juice does NOT contain provitamin A carotenoids (beta-carotene, alpha-carotene), nor the non-provitamin A carotenoid, lycopene, but contains anthocyanins.
| Study group | Role | What they receive |
|---|---|---|
| Starting with Purple-Red Carrot Juice | Active comparator | Participants are randomized to consume purple-red carrot juice first (250 mL) in under 2 minutes. They will crossover to red carrot juice and to purple carrot juice. Receives: Other: Purple-Red Carrot Juice; Other: Red Carrot Juice; Other: Purple Carrot Juice |
| Starting with Purple Carrot Juice | Active comparator | Participants are randomized to consume purple carrot juice first (250 mL) in under 2 minutes. They will crossover to red carrot juice and to purple-red carrot juice. Receives: Other: Purple-Red Carrot Juice; Other: Red Carrot Juice; Other: Purple Carrot Juice |
| Starting with Red Carrot Juice | Active comparator | Participants are randomized to consume red carrot juice first (250 mL) in under 2 minutes. They will crossover to purple-red carrot juice and to purple carrot juice. Receives: Other: Purple-Red Carrot Juice; Other: Red Carrot Juice; Other: Purple Carrot Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in serum retinol concentration
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Measured: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Change in serum carotenoid concentration
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Measured: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Change in serum anthocyanin concentration
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Measured: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Secondary outcomes (6)
Change in antioxidant capacity of the carrots and carrot juice measured by enzyme activity assay
Three different antioxidant activity assays will be used including the Oxygen Radical Absorbance Capacity (ORAC), 2,2'-azino-bis-3-ethylbenzthiazoline-6-sulphonic acid (ABTS+), and 1,1-diphenyl-2-picrylhydrazyl (DPPH) assays, all of which will be analyzed by Ultraviolet (UV) spec. Each method analyzes different ways anthocyanins and carotenoids may act as antioxidants, and a combination of the three will more accurately represent the parameters of human biology. Data will be expressed as Trolox equivalent antioxidant capacity (TEAC).
Measured: up to 1 month
Change in alpha-glucosidase inhibition activities of the carrots and carrot juice measured by enzyme activity assay
Enzyme inhibition will be assessed using specific enzymatic assay kits for alpha-glucosidase and alpha-amylase, analyzed using Enzyme-Linked Immunosorbent Assay (ELISA), and results will be expressed as IC50 (% inhibition).
Measured: up to 1 month
Change in alpha-amylase inhibition activities of the carrots and carrot juice measured by enzyme activity assay
Enzyme inhibition will be assessed using specific enzymatic assay kits for alpha-glucosidase and alpha-amylase, analyzed using ELISA, and results will be expressed as IC50 (% inhibition).
Measured: up to 1 month
Change in serum glucose concentration
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Measured: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Change in serum insulin concentration
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Measured: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Change in serum incretin concentration
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Measured: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start31 Oct 2022
- Primary completion11 May 2023
- Study completion11 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05319548
- Sponsor's protocol ID
- 2021-1544
- Other IDs
- Protocol Version 6/9/2022, A074600, 59-5090-2-003
- Status last verified
- May 2023
- First submitted
- 29 Mar 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plant Pigments for Human Health: Determining the Interactions the Impact of Co-ingestion of Carotenoids and Anthocyanins From Multicolored Carrots on the Bioavailability of Provitamin A Carotenoids and the Impact on Each Pigment Groups' Respective Antidiabetic Activity in Humans
- ClinicalTrials.gov ID
- NCT05319548
- Acronym / sponsor ID
- 2021-1544
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 11 May 2023 (actual)
- Study completion
- 11 May 2023 (actual)
- First posted
- 8 Apr 2022 (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 proposed research will help characterize the impact that simultaneous consumption of anthocyanins and carotenoids has on the bioavailability of the provitamin A carotenoids a-carotene and b-carotene and the non-provitamin A carotenoid lycopene, and on their respective antidiabetic activity in humans. The central hypothesis is that provitamin A carotenoids will be bioavailable from purple-red multicolored carrots in humans, and the co-ingestion of carotenoids and anthocyanins from these carrots will have synergistic impacts on their respective antioxidant and antidiabetic effects. This hypothesis will be assessed through a 53 day randomized crossover time course study that consists of three arms in which healthy males and females ages 18-40 (n = 12) will consume carrot juice prepared from red, purple-red, or purple carrots. During each arm, participants will switch the type of juice they consume and by the end of the third arm, all participants will have ingested juice made from all three carrot varieties. Blood will be collected at multiple time points over 72 hours following consumption.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Starting with Purple-Red Carrot Juice | Active comparator | Other: Purple-Red Carrot Juice, Other: Red Carrot Juice, Other: Purple Carrot JuiceParticipants are randomized to consume purple-red carrot juice first (250 mL) in under 2 minutes. They will crossover to red carrot juice and to purple carrot juice. |
| Starting with Purple Carrot Juice | Active comparator | Other: Purple-Red Carrot Juice, Other: Red Carrot Juice, Other: Purple Carrot JuiceParticipants are randomized to consume purple carrot juice first (250 mL) in under 2 minutes. They will crossover to red carrot juice and to purple-red carrot juice. |
| Starting with Red Carrot Juice | Active comparator | Other: Purple-Red Carrot Juice, Other: Red Carrot Juice, Other: Purple Carrot JuiceParticipants are randomized to consume red carrot juice first (250 mL) in under 2 minutes. They will crossover to purple-red carrot juice and to purple carrot juice. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy
- Non-smoking
- Not pregnant (or planning to become pregnant)
- Body Mass Index (BMI) greater than 18.5 and less than 30
Key exclusion criteria (9 listed)
- Major comorbidities (cardiovascular disease (CVD), diabetes, cancer, kidney/liver/bowel disease)
- History of malabsorptive/GI disorders
- Abnormal diet
- BMI less than 18.5 or greater than 30
- Food intolerances/allergies/hypersensitivities
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 |
|---|---|---|
| Purple-Red Carrot JuicePurple-Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), the non-provitamin A carotenoid, lycopene, as well as anthocyanins | Other | Starting with Purple Carrot Juice, Starting with Purple-Red Carrot Juice, Starting with Red Carrot Juice |
| Red Carrot JuiceRed carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), and the non-provitamin A carotenoid, lycopene, but does NOT contain anthocyanins.. | Other | Starting with Purple Carrot Juice, Starting with Purple-Red Carrot Juice, Starting with Red Carrot Juice |
| Purple Carrot JuicePurple carrot juice does NOT contain provitamin A carotenoids (beta-carotene, alpha-carotene), nor the non-provitamin A carotenoid, lycopene, but contains anthocyanins. | Other | Starting with Purple Carrot Juice, Starting with Purple-Red Carrot Juice, Starting with Red Carrot Juice |
Primary outcome
Change in serum retinol concentration
Time frame: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Change in serum carotenoid concentration
Time frame: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Change in serum anthocyanin concentration
Time frame: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
6 secondary outcomes
Change in antioxidant capacity of the carrots and carrot juice measured by enzyme activity assay
Time frame: up to 1 month
Change in alpha-glucosidase inhibition activities of the carrots and carrot juice measured by enzyme activity assay
Time frame: up to 1 month
Change in alpha-amylase inhibition activities of the carrots and carrot juice measured by enzyme activity assay
Time frame: up to 1 month
Change in serum glucose concentration
Time frame: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Change in serum insulin concentration
Time frame: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
Change in serum incretin concentration
Time frame: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours
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 18 Dec 2025.
- Individual participant dataSharing planned: No
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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 Purple-Red Carrot Juice, Red Carrot Juice and Purple Carrot Juice in people with Healthy, run by University of Wisconsin, Madison 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 4 inclusion and 9 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 18 Dec 2025. 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 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 serum retinol concentration (time frame: Blood will be drawn on the first test day (treatment day) at baseline, 15 minutes, 30 minutes, 45 minutes, 1 hour, 2.5 hours, 4 hours, 6 hours, 9 hours, 24 hours, 72 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Dec 2025.