Novel Metabolites of Beta-Carotene and Lycopene

Beltsville Human Nutrition Research Center (BHNRC)

Status: Completed

Conditions: Healthy

Treatments: Other: Base diet + high lycopene tomato juice; Other: Base diet + placebo beverage; Other: Base diet + high beta-carotene tomato juice

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT02550483

HS51

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 21 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups, including a placebo group

Beta-Carotene Tomato Juice

Active Comparator group

Description:

Participants will receive high beta-carotene tomato juice daily as part of controlled diet (base diet + high beta-carotene tomato juice).

Treatment:

Other: Base diet + high beta-carotene tomato juice

Lycopene Tomato Juice

Active Comparator group

Description:

Participants will receive high lycopene tomato juice daily as part of controlled diet (base diet + high lycopene tomato juice).

Treatment:

Other: Base diet + high lycopene tomato juice

Placebo Beverage

Placebo Comparator group

Description:

Participants will receive placebo beverage daily as part of controlled diet (base diet + placebo beverage).

Treatment:

Other: Base diet + placebo beverage