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

University of Wisconsin (UW)

Status: Completed

Conditions: Healthy

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05319548

2021-1544

A074600 (Other Identifier)

59-5090-2-003 (Other Grant/Funding Number)

Protocol Version 6/9/2022 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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12 participants in 3 patient groups

Starting with Purple-Red Carrot Juice

Active Comparator group

Description:

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.

Treatment:

Other: Red Carrot Juice

Other: Purple Carrot Juice

Other: Purple-Red Carrot Juice

Starting with Purple Carrot Juice

Active Comparator group

Description:

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.

Treatment:

Other: Red Carrot Juice

Other: Purple Carrot Juice

Other: Purple-Red Carrot Juice

Starting with Red Carrot Juice

Active Comparator group

Description:

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.

Treatment:

Other: Red Carrot Juice

Other: Purple Carrot Juice

Other: Purple-Red Carrot Juice