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Clinical Trials/NCT05319548
NCT05319548
Completed
Not Applicable

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

University of Wisconsin, Madison1 site in 1 country12 target enrollmentOctober 31, 2022
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of Wisconsin, Madison
Enrollment
12
Locations
1
Primary Endpoint
Change in serum retinol concentration
Status
Completed
Last Updated
4 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 31, 2022
End Date
May 11, 2023
Last Updated
4 months ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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).

Outcomes

Primary Outcomes

Change in serum retinol concentration

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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 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 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)
  • Change in alpha-amylase inhibition activities of the carrots and carrot juice measured by enzyme activity assay(up to 1 month)
  • 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 Sites (1)

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