Effects of Black Pepper on the Absorption of Nutrients in Vegetables

Absorption Clinical Trial

Official title:

Effects of Black Pepper on the Absorption of Nutrients in Vegetables

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03490955
• Other study ID #: 2017-3973
• Status: Completed
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: November 30, 2019

Study information

• Verified date: March 2020
• Source: University of Massachusetts, Amherst
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 30, 2019
• Est. primary completion date: June 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Absorption
• Black Pepper
• Carotenoid

Intervention

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
• salad dressing (canola oil)
Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning
• black pepper
Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning
• salad
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 pepper
Subjects will consume a vegetable salad with black pepper and dressing (olive oil) one time in the morning
• 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
• 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
• 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

Locations

Country	Name	City	State
United States	Institute for Applied Life Sciences	Amherst	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
University of Massachusetts, Amherst

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the level of carotenoids in blood	Utilize HPLC to quantify blood levels of carotenoids in subjects consumed test articles	12-16 weeks