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

Healthy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319548
• Other study ID #: 2021-1544
• Secondary ID: Protocol Version
• Status: Completed
• Phase: N/A
• Start date: October 31, 2022
• Est. completion date: May 11, 2023

Study information

• Verified date: May 2023
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: May 11, 2023
• Est. primary completion date: May 11, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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).

Related Conditions & MeSH terms

• Healthy

Intervention

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
• 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..
• 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.

Locations

Country	Name	City	State
United States	UW-Madison Department of Nutritional Sciences	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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).	up to 1 month
Secondary	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).	up to 1 month
Secondary	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).	up to 1 month
Secondary	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)	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	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)	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	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)	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