Novel Metabolites of Beta-Carotene and Lycopene

NCT02550483 | Completed

• 1 other identifier: HS51
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Healthy volunteers

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Change in global gene expression

  Baseline, 4 weeks

• Change in proportion of phyla of colonic microbiota

  Baseline, 4 weeks

• Identification of unknown urinary carotenoid metabolites

  Baseline, 2 weeks, 4 weeks

Study Arms (3)

Beta-Carotene Tomato Juice

ACTIVE COMPARATOR

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

Lycopene Tomato Juice

ACTIVE COMPARATOR

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

Placebo Beverage

PLACEBO COMPARATOR

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

Other: Base diet + placebo beverage

Interventions

Base diet + high beta-carotene tomato juice 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.

Beta-Carotene Tomato Juice

Base diet + high lycopene tomato juice 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.

Lycopene Tomato Juice

Base diet + placebo beverage 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.

Placebo Beverage

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• USDA Beltsville Human Nutrition Research Center: lead

Study Sites (1)

USDA Beltsville Human Nutrition Research Center

Beltsville, Maryland, 20705, United States

Location

Related Publications (1)

• 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.

  PMID: 30239552 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Physiologist

Study Record Dates

• First Submitted: September 8, 2015
• First Posted: September 15, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: April 26, 2018

Record last verified: 2018-04

Locations

US (1)