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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Lycopene Tomato Juice | Active Comparator | Participants will receive high lycopene tomato juice daily as part of controlled diet (base diet + high lycopene tomato juice). |
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| Placebo Beverage | Placebo Comparator | Participants will receive placebo beverage daily as part of controlled diet (base diet + placebo beverage). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USDA Beltsville Human Nutrition Research Center | Beltsville | Maryland | 20705 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30239552 | Derived | 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. |
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| 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. |
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| 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. |
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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 |