Effects of Black Pepper on the Absorption of Nutrients in Vegetables

• ClinicalTrials.gov Identifier: NCT03490955
• Recruitment Status: Unknown
• First Posted: April 6, 2018
• Last Update Posted: November 16, 2018
• Sponsor: University of Massachusetts, Amherst
• Information provided by (Responsible Party): University of Massachusetts, Amherst

Study Description

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 and black pepper; Other: salad dressing; Other: black pepper; Other: salad	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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated 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
• Estimated Study Start Date: December 6, 2018
• Estimated Primary Completion Date: June 15, 2019
• Estimated Study Completion Date: June 30, 2019

Arms and Interventions

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 and without black pepper one time in the morning
Active Comparator: Salad dressing; Subjects will consume a vegetable salad with dressing one time in the morning	Other: salad dressing; Subjects will consume a vegetable salad with dressing one time in the morning
Active Comparator: black pepper; Subjects will consume a vegetable salad without dressing but with black pepper one time in the morning	Other: black pepper; Subjects will consume a vegetable salad without dressing but with black pepper one time in the morning
Active Comparator: Salad dressing and black pepper; Subjects will consume a vegetable salad with dressing and with black pepper one time in the morning	Other: salad dressing and black pepper; Subjects will consume a vegetable salad with black pepper and dressing one time in the morning

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: Hang Xiao; 4135452281; hangxiao@foodsci.umass.edu

Contact: Zhengze Li; 4135452281; zhengzeli@foodsci.umass.edu

Sponsors and Collaborators

University of Massachusetts, Amherst

More Information

• Responsible Party: University of Massachusetts, Amherst
• ClinicalTrials.gov Identifier: NCT03490955
• Other Study ID Numbers: 2017-3973
• First Posted: April 6, 2018
• Last Update Posted: November 16, 2018
• Last Verified: September 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No