Effects of Black Pepper on the Absorption of Nutrients in Vegetables
1 other identifier
interventional
16
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 30, 2018
CompletedFirst Posted
Study publicly available on registry
April 6, 2018
CompletedStudy Start
First participant enrolled
September 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2019
CompletedApril 30, 2021
March 1, 2020
9 months
March 30, 2018
April 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Determine the level of carotenoids in blood
Utilize HPLC to quantify blood levels of carotenoids in subjects consumed test articles
12-16 weeks
Study Arms (8)
Salad
SHAM COMPARATORSubjects will consume a vegetable salad without dressing one time in the morning.
Salad dressing (canola oil)
ACTIVE COMPARATORSubjects will consume a vegetable salad with dressing (canola oil) one time in the morning
black pepper
ACTIVE COMPARATORSubjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning
Salad dressing (canola oil) and black pepper
ACTIVE COMPARATORSubjects will consume a vegetable salad with dressing (canola oil) and with black pepper one time in the morning
Salad dressing (olive oil) and black pepper
ACTIVE COMPARATORSubjects will consume a vegetable salad with dressing (olive oil) and with black pepper one time in the morning
Salad dressing (corn oil) and black pepper
ACTIVE COMPARATORSubjects will consume a vegetable salad with dressing (corn oil) and with black pepper one time in the morning
Salad dressing (sunflower oil) and black pepper
ACTIVE COMPARATORSubjects will consume a vegetable salad with dressing (sunflower oil) and with black pepper one time in the morning
Salad dressing (flaxseed oil) and black pepper
ACTIVE COMPARATORSubjects will consume a vegetable salad with dressing (flaxseed oil) and with black pepper one time in the morning
Interventions
Subjects will consume a vegetable salad with black pepper and dressing (canola oil) one time in the morning
Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning
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) and without 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
Subjects will consume a vegetable salad with black pepper and dressing (corn oil) one time in the morning
Subjects will consume a vegetable salad with black pepper and dressing (sunflower oil) one time in the morning
Subjects will consume a vegetable salad with black pepper and dressing (flaxseed oil) one time in the morning
Eligibility Criteria
You may qualify if:
- year old healthy adults
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute for Applied Life Sciences
Amherst, Massachusetts, 01003, United States
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 30, 2018
First Posted
April 6, 2018
Study Start
September 6, 2018
Primary Completion
June 15, 2019
Study Completion
November 30, 2019
Last Updated
April 30, 2021
Record last verified: 2020-03