Clinical trial NCT05319548: Plant Pigments for Human Health: Impact of Lycopene and Anthocyanins on Bioefficacy of Provitamin A Carotenoids From Carrots
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Change in serum retinol concentration
timeFrame: 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
measure: Change in serum carotenoid concentration
timeFrame: 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
measure: Change in serum anthocyanin concentration
timeFrame: 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:
measure: Change in antioxidant capacity of the carrots and carrot juice measured by enzyme activity assay
timeFrame: up to 1 month
measure: Change in alpha-glucosidase inhibition activities of the carrots and carrot juice measured by enzyme activity assay
timeFrame: up to 1 month
measure: Change in alpha-amylase inhibition activities of the carrots and carrot juice measured by enzyme activity assay
timeFrame: up to 1 month
measure: Change in serum glucose concentration
timeFrame: 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
measure: Change in serum insulin concentration
timeFrame: 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
measure: Change in serum incretin concentration
timeFrame: 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
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW-Madison Department of Nutritional Sciences
state: Wisconsin
Study officials:
References: