Novel Metabolites of Beta-Carotene and Lycopene
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Change in apocarotenoid concentrations will be measured in blood
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 21 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- Not provided
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
Arms & Interventions
Beta-Carotene Tomato Juice
Participants will receive high beta-carotene tomato juice daily as part of controlled diet (base diet + high beta-carotene tomato juice).
Intervention: Base diet + high beta-carotene tomato juice (Other)
Lycopene Tomato Juice
Participants will receive high lycopene tomato juice daily as part of controlled diet (base diet + high lycopene tomato juice).
Intervention: Base diet + high lycopene tomato juice (Other)
Placebo Beverage
Participants will receive placebo beverage daily as part of controlled diet (base diet + placebo beverage).
Intervention: Base diet + placebo beverage (Other)
Outcomes
Primary Outcomes
Change in apocarotenoid concentrations will be measured in blood
Time Frame: Baseline, 2 weeks, 4 weeks
Apocarotenoid concentrations will be measured in blood (baseline, after washout; 2 wks; 4 wks).
Change in carotenoid concentrations will be measured in blood
Time Frame: Baseline, 2 weeks, 4 weeks
Carotenoid concentrations will be measured in blood (baseline, after washout; 2 wks, 4 wks).
Secondary Outcomes
- Identification of unknown urinary carotenoid metabolites(Baseline, 2 weeks, 4 weeks)
- Change in proportion of phyla of colonic microbiota(Baseline, 4 weeks)
- Change in global gene expression(Baseline, 4 weeks)
Investigators
Janet Novotny
Research Physiologist
USDA Beltsville Human Nutrition Research Center