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

Sponsor

University of Wisconsin, Madison (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05319548

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

7.5

Patients Per Site Per Month

Study Details

Study Description

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 = 15) 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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Purple-Red Carrot Juice Other: Red Carrot Juice Other: Purple Carrot Juice	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

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

Anticipated Study Start Date :

Sep 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Other: 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 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.. 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.
Active Comparator: 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.	Other: 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 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.. 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.
Active Comparator: 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.	Other: 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 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.. 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.

Arm

Intervention/Treatment

Active Comparator: 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.

Other: 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

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..

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.

Active Comparator: 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.

Other: 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

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..

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.

Active Comparator: 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.

Other: 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

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..

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.

Outcome Measures

Primary Outcome Measures

Change in serum retinol 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]
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 [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 [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)

Secondary Outcome Measures

Change in antioxidant capacity of the carrots and carrot juice measured by enzyme activity assay [up to 1 month]
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).
Change in alpha-glucosidase inhibition activities of the carrots and carrot juice measured by enzyme activity assay [up to 1 month]
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).
Change in alpha-amylase inhibition activities of the carrots and carrot juice measured by enzyme activity assay [up to 1 month]
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).
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]
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
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]
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)
Change in serum incretin 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]
Blood draws will take place on the first, second, and fourth test day (days 8, 9, 11 of each arm)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UW-Madison Department of Nutritional Sciences	Madison	Wisconsin	United States	53706

Sponsors and Collaborators

University of Wisconsin, Madison

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Wisconsin, Madison

ClinicalTrials.gov Identifier:

NCT05319548

Other Study ID Numbers:

2021-1544
Protocol Version 6/9/2022
A074600

First Posted:

Apr 8, 2022

Last Update Posted:

Jul 22, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Jul 22, 2022