- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03490955
Effects of Black Pepper on the Absorption of Nutrients in Vegetables
April 27, 2021 updated by: University of Massachusetts, Amherst
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- Other: salad
- Other: salad dressing (canola oil)
- Other: black pepper
- Other: salad dressing (canola oil) and black pepper
- 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
Detailed Description
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
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
-
Amherst, Massachusetts, United States, 01003
- Institute for Applied Life Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 28 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Sham Comparator: Salad
Subjects will consume a vegetable salad without dressing one time in the morning.
|
Subjects will consume a vegetable salad without dressing (canola oil) and without black pepper one time in the morning
|
Active Comparator: Salad dressing (canola oil)
Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning
|
Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning
|
Active Comparator: black pepper
Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning
|
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
|
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
|
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
|
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
|
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
|
Subjects will consume a vegetable salad with black pepper and dressing (flaxseed oil) one time in the morning
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
12-16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 6, 2018
Primary Completion (Actual)
June 15, 2019
Study Completion (Actual)
November 30, 2019
Study Registration Dates
First Submitted
March 30, 2018
First Submitted That Met QC Criteria
March 30, 2018
First Posted (Actual)
April 6, 2018
Study Record Updates
Last Update Posted (Actual)
April 30, 2021
Last Update Submitted That Met QC Criteria
April 27, 2021
Last Verified
March 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2017-3973
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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