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

NCT05319548 | Completed

• 4 other identifiers: 2021-1544Protocol Version 6/9/2022A07460059-5090-2-003
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (3)

• 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)

  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)

  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)

  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

  up to 1 month

• Change in alpha-glucosidase inhibition activities of the carrots and carrot juice measured by enzyme activity assay

  up to 1 month

• Change in alpha-amylase inhibition activities of the carrots and carrot juice measured by enzyme activity assay

  up to 1 month

• Change in serum glucose concentration

  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 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

Study Arms (3)

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.

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.

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.

Other: Purple-Red Carrot Juice; Other: Red Carrot Juice; Other: Purple Carrot Juice

Interventions

Purple-Red Carrot Juice OTHER

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

Starting with Purple Carrot Juice; Starting with Purple-Red Carrot Juice; Starting with Red Carrot Juice

Red Carrot Juice OTHER

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

Starting with Purple Carrot Juice; Starting with Purple-Red Carrot Juice; Starting with Red Carrot Juice

Purple Carrot Juice 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; Starting with Purple-Red Carrot Juice; Starting with Red Carrot Juice

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

UW-Madison Department of Nutritional Sciences

Madison, Wisconsin, 53706, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 8, 2022
• Study Start: October 31, 2022
• Primary Completion: May 11, 2023
• Study Completion: May 11, 2023
• Last Updated: December 18, 2025

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)