Clinical trial NCT02231502: Innovation in Food Production Techniques to Improve Bioactive Content
Official title: Optimising Vegetable Based Convenience Food Production to Retain Compounds Found in Vegetables
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bioavailability
Keywords: Bioavailability in healthy individuals
Lead sponsor: University of East Anglia
Sponsor class: OTHER
Collaborators: name: Quadram Institute Bioscience
name: PepsiCo Global R&D
First posted: 2014-09-04
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to establish to what extent innovations in food production techniques may facilitate retention of bioactive compounds in healthy individuals.

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.


Eligibility criteria: Inclusion Criteria:

* Men and women
* ≥ 18 years old
* Successful biochemical, haematological and urinalysis assessment at screening

Exclusion Criteria:

* Current smokers, or ex-smokers ceasing \< 3 months ago
* 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.

Primary outcomes:
measure: 24hr excretion of bioactive compounds
timeFrame: 24h
Secondary outcomes:
Other outcomes:
Locations:
city: Norwich
country: United Kingdom
facility: Norwich Medical School
state: Norfolk
Study officials:
affiliation: University of East Anglia
name: Aedin Cassidy, PhD
role: PRINCIPAL_INVESTIGATOR
References: