Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Black Pepper on the Absorption of Nutrients in Vegetables

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03490955
Recruitment Status : Completed
First Posted : April 6, 2018
Last Update Posted : April 30, 2021
Sponsor:
Information provided by (Responsible Party):
University of Massachusetts, Amherst

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

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.

Layout table for study information
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


Arm Intervention/treatment
Sham Comparator: Salad
Subjects will consume a vegetable salad without dressing one time in the morning.
Other: salad
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
Other: salad dressing (canola oil)
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
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
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 :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
United States, Massachusetts
Institute for Applied Life Sciences
Amherst, Massachusetts, United States, 01003
Sponsors and Collaborators
University of Massachusetts, Amherst
Layout table for additonal information
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No