Innovation in Food Production Techniques to Improve Bioactive Content
NCT ID: NCT02231502
Last Updated: 2014-11-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
20 participants
INTERVENTIONAL
2014-07-31
2015-01-31
Brief Summary
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The study has a single-blinded (outcome assessor), cross-over design; wherein, the plasma concentration and urinary excretion levels of a range of bioactive compounds will be assessed over a 24 hour period following intake of either a vegetable based convenience food, or a minimally processed meal containing the same vegetable materials.
To do this, 20 healthy volunteers will attend two assessment days (and a follow-up assessment at +24hr) and will provide blood and urine samples, which will be collected at biologically relevant times over the 24 hour period. In this cross-over study, each meal will be eaten on separate days, with a wash-out period of at least 1 week between assessments.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Vegetable-based convenience food
One time ingestion of a vegetable-based convenience product. Dietary restrictions will be observed (i.e. avoidance of some vegetables) for 3 days prior to the bioavailability assessment (a list of foods to avoid will be provided).
At least 7 days wash-out between each assessment visit.
Vegetable-based convenience food
Vegetable meal
One time ingestion of a minimally processed vegetable meal. Dietary restrictions will be observed (i.e. avoidance of some vegetables) for 3 days prior to the bioavailability assessment (a list of foods to avoid will be provided).
At least 7 days wash-out between each assessment visit.
Vegetable meal
Interventions
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Vegetable-based convenience food
Vegetable meal
Eligibility Criteria
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Inclusion Criteria
* ≥ 18 years old
* Successful biochemical, haematological and urinalysis assessment at screening
Exclusion Criteria
* Pregnant women, or those currently breast feeding
* Subjects with existing or significant past medical history of medical conditions likely to affect the study measures i.e. diabetes, hepatic, renal, digestive or cancer (excluding Basal-cell carcinoma) - to be judged by the study clinical advisor.
* Those unprepared to adhere to dietary restrictions for 3d preceding and during each assessment day.
* Parallel participation in another research project involving dietary intervention and/or sampling of biological fluids/material.
* Those on therapeutic diets or having experienced substantial weight loss (to be judged by clinical advisor) within 3 month of screening
* Taking dietary supplements containing flavonoids, isothiocyanates or carotenes (including multivitamins) (and unwilling to cease intake during, and 1 month preceding the trial) or unwilling to maintain existing intake of other supplements.
* Prescribed medications likely to affect ADME (absorption, distribution, metabolism, and excretion); medications to be assessed for suitability by the clinical advisor.
* Clinical advisor judged: abnormal biochemical, haematological or urinary results or measurements considered to be counter indicative for the study: including kidney and liver function, fasting glucose (especially if indicative of diabetes), lipid abnormalities, full blood count.
18 Years
ALL
Yes
Sponsors
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Quadram Institute Bioscience
OTHER
PepsiCo Global R&D
INDUSTRY
University of East Anglia
OTHER
Responsible Party
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Principal Investigators
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Aedin Cassidy, PhD
Role: PRINCIPAL_INVESTIGATOR
University of East Anglia
Locations
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Norwich Medical School
Norwich, Norfolk, United Kingdom
Countries
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Other Identifiers
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14/EE/0070
Identifier Type: -
Identifier Source: org_study_id