Effects of Black Pepper on the Absorption of Nutrients in Vegetables

• ClinicalTrials.gov Identifier: NCT03490955
• Recruitment Status: Completed
• First Posted: April 6, 2018
• Last Update Posted: April 30, 2021
• Sponsor: University of Massachusetts, Amherst
• Information provided by (Responsible Party): University of Massachusetts, Amherst

Tracking Information

• First Submitted Date: March 30, 2018
• First Posted Date: April 6, 2018
• Last Update Posted Date: April 30, 2021
• Actual Study Start Date: September 6, 2018
• Actual Primary Completion Date: June 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 30, 2018)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Black Pepper on the Absorption of Nutrients in Vegetables
• Official Title: Effects of Black Pepper on the Absorption of Nutrients in Vegetables
• 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.
• 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
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

• Black Pepper
• Absorption
• 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
• Other: salad dressing (canola oil)
  Subjects will consume a vegetable salad with dressing (canola oil) 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
• Other: salad
  Subjects will consume a vegetable salad without dressing (canola oil) and without 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
• 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
• 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
• 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

Study Arms

• Sham Comparator: Salad
  Subjects will consume a vegetable salad without dressing one time in the morning.
  Intervention: Other: salad
• Active Comparator: Salad dressing (canola oil)
  Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning
  Intervention: Other: salad dressing (canola oil)
• Active Comparator: black pepper
  Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning
  Intervention: Other: black pepper
• 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
  Intervention: Other: salad dressing (canola oil) and black pepper
• 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
  Intervention: Other: Salad dressing (olive oil) and black pepper
• 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
  Intervention: Other: Salad dressing (corn oil) and black pepper
• 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
  Intervention: Other: Salad dressing (sunflower oil) and black pepper
• 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
  Intervention: Other: Salad dressing (flaxseed oil) and black pepper

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 30, 2018): 16
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: November 30, 2019
• Actual Primary Completion Date: June 15, 2019 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 30 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03490955
• Other Study ID Numbers: 2017-3973
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

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

• IPD Sharing Statement: Not Provided
• Current Responsible Party: University of Massachusetts, Amherst
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Massachusetts, Amherst
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Massachusetts, Amherst
• Verification Date: March 2020