Clinical trial NCT02550483: Novel Metabolites of Beta-Carotene and Lycopene
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Healthy volunteers
Lead sponsor: USDA Beltsville Human Nutrition Research Center
Sponsor class: FED
First posted: 2015-09-15
Enrollment: 36
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study (n = 36) will be a parallel design and will be 6 weeks in duration. Participants will start with a 2-week free-living wash-in period where they will be asked to avoid certain carotenoid-rich foods, followed by 4 weeks of a completely controlled diet. In addition to the controlled diet, participants will consume one of three beverages (300 mL/day; n = 12/group): placebo beverage (control), high beta-carotene tomato juice, and high-lycopene tomato juice. Blood, urine and feces will be collected throughout the study.


Eligibility criteria: Inclusion Criteria:

Exclusion Criteria:

* Age less than 21 or greater than 75 years
* Glucose \> 126 mg/dl
* Triglycerides \> 300 mg/dl
* Known allergy or intolerance to tomatoes or tomato products
* Pregnant, lactating, or intend to become pregnant during the study period
* History of bariatric surgery or nutrient malabsorption disease (such as celiac disease) or other metabolic disorders requiring special diet recommendations
* Smoker or use of tobacco products
* Presently have cancer
* Use of certain medications (prescription or over-the-counter) that may interfere with the study objectives
* Type 2 diabetes
* Use of blood-thinning medications such as Coumadin (warfarin), Dicumarol, or Miradon (anisindione)
* Unable or unwilling to give informed consent or communicate with study staff
* Self-report of alcohol or substance abuse within the past 12 months and/or current acute treatment or rehabilitation program for these problems (long-term participation in Alcoholics Anonymous is not an exclusion)
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study participation or the ability to follow the intervention protocol

Primary outcomes:
measure: Change in apocarotenoid concentrations will be measured in blood
timeFrame: Baseline, 2 weeks, 4 weeks
measure: Change in carotenoid concentrations will be measured in blood
timeFrame: Baseline, 2 weeks, 4 weeks
Secondary outcomes:
measure: Change in global gene expression
timeFrame: Baseline, 4 weeks
measure: Change in proportion of phyla of colonic microbiota
timeFrame: Baseline, 4 weeks
measure: Identification of unknown urinary carotenoid metabolites
timeFrame: Baseline, 2 weeks, 4 weeks
Other outcomes:
Locations:
city: Beltsville
country: United States
facility: USDA Beltsville Human Nutrition Research Center
state: Maryland
Study officials:
References:
citation: Cooperstone JL, Novotny JA, Riedl KM, Cichon MJ, Francis DM, Curley RW Jr, Schwartz SJ, Harrison EH. Limited appearance of apocarotenoids is observed in plasma after consumption of tomato juices: a randomized human clinical trial. Am J Clin Nutr. 2018 Oct 1;108(4):784-792. doi: 10.1093/ajcn/nqy177.