Novel Metabolites of Beta-Carotene and Lycopene

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Base diet + high beta-carotene tomato juice; Other: Base diet + high lycopene tomato juice; Other: Base diet + placebo beverage

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Beltsville, Maryland, United States, 20705
      • USDA Beltsville Human Nutrition Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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).	Other: 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.
Active Comparator: Lycopene Tomato Juice; Participants will receive high lycopene tomato juice daily as part of controlled diet (base diet + high lycopene tomato juice).	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.
Placebo Comparator: Placebo Beverage; Participants will receive placebo beverage daily as part of controlled diet (base diet + placebo beverage).	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in apocarotenoid concentrations will be measured in blood	Apocarotenoid concentrations will be measured in blood (baseline, after washout; 2 wks; 4 wks).	Baseline, 2 weeks, 4 weeks
Change in carotenoid concentrations will be measured in blood	Carotenoid concentrations will be measured in blood (baseline, after washout; 2 wks, 4 wks).	Baseline, 2 weeks, 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in global gene expression	Amounts of messenger RNA will be measured in blood samples to determine if the consumption of carotenoid-rich foods will affect gene expression of pathways related to cancer risk.	Baseline, 4 weeks
Change in proportion of phyla of colonic microbiota	Ribosomal RNA will be measured to determine relative amounts of different bacterial phyla present in the colon after consumption of the juice products differing in carotenoid concentration.	Baseline, 4 weeks
Identification of unknown urinary carotenoid metabolites	Identify previously unknown carotenoid metabolites in urine.	Baseline, 2 weeks, 4 weeks

Collaborators and Investigators

• Sponsor: USDA Beltsville Human Nutrition Research Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: September 8, 2015
• First Submitted That Met QC Criteria: September 11, 2015
• First Posted (Estimate): September 15, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Healthy volunteers
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Protective Agents; Micronutrients; Vitamins; Antioxidants; Anticarcinogenic Agents; Radiation-Protective Agents; Provitamins; Beta Carotene; Carotenoids; Lycopene
• Other Study ID Numbers: HS51