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

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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