Effects of Black Pepper on the Absorption of Nutrients in Vegetables
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| ClinicalTrials.gov Identifier: NCT03490955 |
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Recruitment Status :
Completed
First Posted : April 6, 2018
Last Update Posted : April 30, 2021
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Sponsor:
University of Massachusetts, Amherst
Information provided by (Responsible Party):
University of Massachusetts, Amherst
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Brief Summary:
The objective of this project is to determine the extent to which eating black pepper together with vegetables increase the absorption of carotenoids (a class of important nutrients) in the vegetables such as beta-carotene.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Black Pepper Absorption Carotenoid | Other: salad dressing (canola oil) and black pepper Other: salad dressing (canola oil) Other: black pepper Other: salad Other: Salad dressing (olive oil) and black pepper Other: Salad dressing (corn oil) and black pepper Other: Salad dressing (sunflower oil) and black pepper Other: Salad dressing (flaxseed oil) and black pepper | Not Applicable |
Black pepper has multiple health-promoting effects, many of which are associated with the relatively high levels of piperine it contains. Piperine can enhance the oral bioavailability of nutraceuticals in foods due to its inhibitory activity on drug metabolizing enzymes such as cytochrome P450 and p-glycoprotein in the gastrointestinal mucosa. This decreases the first-pass metabolism of nutraceuticals thus increasing their levels in the systemic circulation. Numerous studies in both animals and humans have validated the efficacy of piperine in boosting nutraceutical bioavailability. However, most of these studies utilized highly purified sources of both piperine and nutraceuticals, and therefore do not provide direct evidence on the ability of black pepper (used as a spice) to enhance the bioavailability of nutraceuticals in real foods.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 16 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Single (Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Effects of Black Pepper on the Absorption of Nutrients in Vegetables |
| Actual Study Start Date : | September 6, 2018 |
| Actual Primary Completion Date : | June 15, 2019 |
| Actual Study Completion Date : | November 30, 2019 |
Resource links provided by the National Library of Medicine
MedlinePlus related topics:
Black and African American Health
Drug Information available for:
Black pepper
| Arm | Intervention/treatment |
|---|---|
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Sham Comparator: Salad
Subjects will consume a vegetable salad without dressing one time in the morning.
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Other: salad
Subjects will consume a vegetable salad without dressing (canola oil) and without black pepper one time in the morning |
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Active Comparator: Salad dressing (canola oil)
Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning
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Other: salad dressing (canola oil)
Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning |
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Active Comparator: black pepper
Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning
|
Other: black pepper
Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning |
|
Active Comparator: Salad dressing (canola oil) and black pepper
Subjects will consume a vegetable salad with dressing (canola oil) and with black pepper one time in the morning
|
Other: salad dressing (canola oil) and black pepper
Subjects will consume a vegetable salad with black pepper and dressing (canola oil) one time in the morning |
|
Active Comparator: Salad dressing (olive oil) and black pepper
Subjects will consume a vegetable salad with dressing (olive oil) and with black pepper one time in the morning
|
Other: Salad dressing (olive oil) and black pepper
Subjects will consume a vegetable salad with black pepper and dressing (olive oil) one time in the morning |
|
Active Comparator: Salad dressing (corn oil) and black pepper
Subjects will consume a vegetable salad with dressing (corn oil) and with black pepper one time in the morning
|
Other: Salad dressing (corn oil) and black pepper
Subjects will consume a vegetable salad with black pepper and dressing (corn oil) one time in the morning |
|
Active Comparator: Salad dressing (sunflower oil) and black pepper
Subjects will consume a vegetable salad with dressing (sunflower oil) and with black pepper one time in the morning
|
Other: Salad dressing (sunflower oil) and black pepper
Subjects will consume a vegetable salad with black pepper and dressing (sunflower oil) one time in the morning |
|
Active Comparator: Salad dressing (flaxseed oil) and black pepper
Subjects will consume a vegetable salad with dressing (flaxseed oil) and with black pepper one time in the morning
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Other: Salad dressing (flaxseed oil) and black pepper
Subjects will consume a vegetable salad with black pepper and dressing (flaxseed oil) one time in the morning |
Primary Outcome Measures :
- Determine the level of carotenoids in blood [ Time Frame: 12-16 weeks ]Utilize HPLC to quantify blood levels of carotenoids in subjects consumed test articles
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| Ages Eligible for Study: | 18 Years to 30 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 18-30 year old healthy adults
Exclusion Criteria:
- those who are <18 or >30 years old, have a BMI of <20 or >29 kg/m2, have a weight change >4.5 kg (9.91 pounds) in the past 3 months, exceed exercise activities of a recreational level over the past 3 months, have any diseases, especially intestinal disorders including lipid malabsorption or lactose intolerance, had abnormal liver or kidney function tests.
- Those who smoke, consume more than two alcoholic drinks per day, use medication affecting lipid profiles or dietary supplements affecting plasma cholesterol (e.g., Benocol or fiber supplements) will also be excluded.
- Additionally, this study excludes menopausal women, those using hormone-based contraceptives, those with abnormal menstrual cycles, and those who are pregnant, lactating or planning to become pregnant.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03490955
Locations
| United States, Massachusetts | |
| Institute for Applied Life Sciences | |
| Amherst, Massachusetts, United States, 01003 | |
Sponsors and Collaborators
University of Massachusetts, Amherst
| Responsible Party: | University of Massachusetts, Amherst |
| ClinicalTrials.gov Identifier: | NCT03490955 |
| Other Study ID Numbers: |
2017-3973 |
| First Posted: | April 6, 2018 Key Record Dates |
| Last Update Posted: | April 30, 2021 |
| Last Verified: | March 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |