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Plant Pigments for Human Health: Impact of Lycopene and Anthocyanins on Bioefficacy of Provitamin A Carotenoids From Carrots

NCT ID: NCT05319548

Last Updated: 2025-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-31

Study Completion Date

2023-05-11

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Starting with Purple-Red Carrot Juice

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.

Group Type ACTIVE_COMPARATOR

Purple-Red Carrot Juice

Intervention Type OTHER

Purple-Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), the non-provitamin A carotenoid, lycopene, as well as anthocyanins

Red Carrot Juice

Intervention Type OTHER

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 Juice

Intervention Type OTHER

Purple carrot juice does NOT contain provitamin A carotenoids (beta-carotene, alpha-carotene), nor the non-provitamin A carotenoid, lycopene, but contains anthocyanins.

Starting with Purple Carrot Juice

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.

Group Type ACTIVE_COMPARATOR

Purple-Red Carrot Juice

Intervention Type OTHER

Purple-Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), the non-provitamin A carotenoid, lycopene, as well as anthocyanins

Red Carrot Juice

Intervention Type OTHER

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 Juice

Intervention Type OTHER

Purple carrot juice does NOT contain provitamin A carotenoids (beta-carotene, alpha-carotene), nor the non-provitamin A carotenoid, lycopene, but contains anthocyanins.

Starting with Red Carrot Juice

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.

Group Type ACTIVE_COMPARATOR

Purple-Red Carrot Juice

Intervention Type OTHER

Purple-Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), the non-provitamin A carotenoid, lycopene, as well as anthocyanins

Red Carrot Juice

Intervention Type OTHER

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 Juice

Intervention Type OTHER

Purple carrot juice does NOT contain provitamin A carotenoids (beta-carotene, alpha-carotene), nor the non-provitamin A carotenoid, lycopene, but contains anthocyanins.

Interventions

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Purple-Red Carrot Juice

Purple-Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), the non-provitamin A carotenoid, lycopene, as well as anthocyanins

Intervention Type OTHER

Red Carrot Juice

Red carrot juice contains provitamin A carotenoids (beta-carotene, alpha-carotene), and the non-provitamin A carotenoid, lycopene, but does NOT contain anthocyanins..

Intervention Type OTHER

Purple Carrot Juice

Purple carrot juice does NOT contain provitamin A carotenoids (beta-carotene, alpha-carotene), nor the non-provitamin A carotenoid, lycopene, but contains anthocyanins.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Non-smoking
* Not pregnant (or planning to become pregnant)
* Body Mass Index (BMI) greater than 18.5 and less than 30

Exclusion Criteria

* 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
* 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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UW-Madison Department of Nutritional Sciences

Madison, Wisconsin, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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Protocol Version 6/9/2022

Identifier Type: OTHER

Identifier Source: secondary_id

A074600

Identifier Type: OTHER

Identifier Source: secondary_id

59-5090-2-003

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2021-1544

Identifier Type: -

Identifier Source: org_study_id