Novel Metabolites of Beta-Carotene and Lycopene

NCT ID: NCT02550483

Last Updated: 2018-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2015-11-30

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.

Conditions

Healthy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: ACTIVE_COMPARATOR

Base diet + high beta-carotene tomato juice

Intervention Type: OTHER

Participants will receive high beta-carotene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.

Lycopene Tomato Juice

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

Group Type: ACTIVE_COMPARATOR

Base diet + high lycopene tomato juice

Intervention Type: OTHER

Participants will receive high lycopene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.

Placebo Beverage

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

Group Type: PLACEBO_COMPARATOR

Base diet + placebo beverage

Intervention Type: OTHER

Participants will receive a placebo beverage daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.

Interventions

Base diet + high beta-carotene tomato juice

Participants will receive high beta-carotene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.

Intervention Type: OTHER

Base diet + high lycopene tomato juice

Participants will receive high lycopene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.

Intervention Type: OTHER

Base diet + placebo beverage

Participants will receive a placebo beverage daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

USDA Beltsville Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Janet Novotny

Research Physiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30239552 (View on PubMed)

Other Identifiers

HS51

Identifier Type: -

Identifier Source: org_study_id