Novel Metabolites of Beta-Carotene and Lycopene
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 4/28/2018 |
| Start Date: | September 2015 |
| End Date: | November 2015 |
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.
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.
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
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