Novel Metabolites of Beta-Carotene and Lycopene
Completed · Not applicable · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT02550483
- Run by
- USDA Beltsville Human Nutrition Research Center
- People needed
- 36
- Starts
- 2015-09-01
- Expected to finish
- 2015-11-01
- Last updated by the study team
- 2018-04-26
Who can join
Age: 21 and older, up to 75. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
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
- 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
Where it is running
- USDA Beltsville Human Nutrition Research Center — Beltsville, Maryland, United States
Full record on ClinicalTrials.gov
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