Black PepperNCT03490955
Effects of Black Pepper on the Absorption of Nutrients in Vegetables
A study testing salad dressing (canola oil) and black pepper, salad dressing (canola oil) and black pepper in people with Black Pepper and Absorption, run by University of Massachusetts, Amherst at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Black Pepper, Absorption, Carotenoid
- What is being tested?
- salad dressing (canola oil) and black pepper, salad dressing (canola oil) and black pepper
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Sep 2018to 30 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-30 year old healthy adults
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Applied Life Sciences
Amherst, Massachusetts, 01003
About this study
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.
Read the 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.
- Conditions
- Black Pepper, Absorption, Carotenoid
- Being tested
- salad dressing (canola oil) and black pepper, salad dressing (canola oil), black pepper, salad, Salad dressing (olive oil) and black pepper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
salad dressing (canola oil) and black pepperOther
Subjects will consume a vegetable salad with black pepper and dressing (canola oil) one time in the morning
salad dressing (canola oil)Other
Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning
black pepperOther
Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning
saladOther
Subjects will consume a vegetable salad without dressing (canola oil) and without black pepper one time in the morning
Salad dressing (olive oil) and black pepperOther
Subjects will consume a vegetable salad with black pepper and dressing (olive oil) one time in the morning
Salad dressing (corn oil) and black pepperOther
Subjects will consume a vegetable salad with black pepper and dressing (corn oil) one time in the morning
Salad dressing (sunflower oil) and black pepperOther
Subjects will consume a vegetable salad with black pepper and dressing (sunflower oil) one time in the morning
Salad dressing (flaxseed oil) and black pepperOther
Subjects will consume a vegetable salad with black pepper and dressing (flaxseed oil) one time in the morning
| Study group | Role | What they receive |
|---|---|---|
| Salad | Sham comparator | Subjects will consume a vegetable salad without dressing one time in the morning. Receives: Other: salad |
| Salad dressing (canola oil) | Active comparator | Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning Receives: Other: salad dressing (canola oil) |
| black pepper | Active comparator | Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning Receives: Other: black pepper |
| Salad dressing (canola oil) and black pepper | Active comparator | Subjects will consume a vegetable salad with dressing (canola oil) and with black pepper one time in the morning Receives: Other: salad dressing (canola oil) and black pepper |
| Salad dressing (olive oil) and black pepper | Active comparator | Subjects will consume a vegetable salad with dressing (olive oil) and with black pepper one time in the morning Receives: Other: Salad dressing (olive oil) and black pepper |
| Salad dressing (corn oil) and black pepper | Active comparator | Subjects will consume a vegetable salad with dressing (corn oil) and with black pepper one time in the morning Receives: Other: Salad dressing (corn oil) and black pepper |
| Salad dressing (sunflower oil) and black pepper | Active comparator | Subjects will consume a vegetable salad with dressing (sunflower oil) and with black pepper one time in the morning Receives: Other: Salad dressing (sunflower oil) and black pepper |
| Salad dressing (flaxseed oil) and black pepper | Active comparator | Subjects will consume a vegetable salad with dressing (flaxseed oil) and with black pepper one time in the morning Receives: Other: Salad dressing (flaxseed oil) and black pepper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine the level of carotenoids in blood
Utilize HPLC to quantify blood levels of carotenoids in subjects consumed test articles
Measured: 12-16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start6 Sep 2018
- Primary completion15 Jun 2019
- Study completion30 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Black PepperStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Amherst
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03490955
- Sponsor's protocol ID
- 2017-3973
- Status last verified
- Mar 2020
- First submitted
- 30 Mar 2018
- Last updated
- 30 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Black Pepper on the Absorption of Nutrients in Vegetables
- ClinicalTrials.gov ID
- NCT03490955
- Acronym / sponsor ID
- 2017-3973
- Conditions
- Black Pepper, Absorption, Carotenoid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Massachusetts, AmherstUniversity, hospital or other
- Study start
- 6 Sep 2018 (actual)
- Primary completion
- 15 Jun 2019 (actual)
- Study completion
- 30 Nov 2019 (actual)
- First posted
- 6 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Salad | Sham comparator | Other: saladSubjects will consume a vegetable salad without dressing one time in the morning. |
| Salad dressing (canola oil) | Active comparator | Other: salad dressing (canola oil)Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning |
| black pepper | Active comparator | Other: black pepperSubjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning |
| Salad dressing (canola oil) and black pepper | Active comparator | Other: salad dressing (canola oil) and black pepperSubjects will consume a vegetable salad with dressing (canola oil) and with black pepper one time in the morning |
| Salad dressing (olive oil) and black pepper | Active comparator | Other: Salad dressing (olive oil) and black pepperSubjects will consume a vegetable salad with dressing (olive oil) and with black pepper one time in the morning |
| Salad dressing (corn oil) and black pepper | Active comparator | Other: Salad dressing (corn oil) and black pepperSubjects will consume a vegetable salad with dressing (corn oil) and with black pepper one time in the morning |
| Salad dressing (sunflower oil) and black pepper | Active comparator | Other: Salad dressing (sunflower oil) and black pepperSubjects will consume a vegetable salad with dressing (sunflower oil) and with black pepper one time in the morning |
| Salad dressing (flaxseed oil) and black pepper | Active comparator | Other: Salad dressing (flaxseed oil) and black pepperSubjects will consume a vegetable salad with dressing (flaxseed oil) and with black pepper one time in the morning |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-30 year old healthy adults
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| salad dressing (canola oil) and black pepperSubjects will consume a vegetable salad with black pepper and dressing (canola oil) one time in the morning | Other | Salad dressing (canola oil) and black pepper |
| salad dressing (canola oil)Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning | Other | Salad dressing (canola oil) |
| black pepperSubjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning | Other | black pepper |
| saladSubjects will consume a vegetable salad without dressing (canola oil) and without black pepper one time in the morning | Other | Salad |
| Salad dressing (olive oil) and black pepperSubjects will consume a vegetable salad with black pepper and dressing (olive oil) one time in the morning | Other | Salad dressing (olive oil) and black pepper |
| Salad dressing (corn oil) and black pepperSubjects will consume a vegetable salad with black pepper and dressing (corn oil) one time in the morning | Other | Salad dressing (corn oil) and black pepper |
| Salad dressing (sunflower oil) and black pepperSubjects will consume a vegetable salad with black pepper and dressing (sunflower oil) one time in the morning | Other | Salad dressing (sunflower oil) and black pepper |
| Salad dressing (flaxseed oil) and black pepperSubjects will consume a vegetable salad with black pepper and dressing (flaxseed oil) one time in the morning | Other | Salad dressing (flaxseed oil) and black pepper |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2021.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing salad dressing (canola oil) and black pepper, salad dressing (canola oil) and black pepper in people with Black Pepper and Absorption, run by University of Massachusetts, Amherst at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the level of carotenoids in blood (time frame: 12-16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2021.