Innovation in Food Production Techniques to Improve Bioactive Content
This trial is active, not recruiting.
|Treatments||vegetable-based convenience food, vegetable meal|
|Sponsor||University of East Anglia|
|Collaborator||Institute of Food Research|
|Start date||July 2014|
|End date||December 2014|
|Trial size||20 participants|
|Trial identifier||NCT02231502, 14/EE/0070|
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.
|Endpoint classification||bio-availability study|
|Intervention model||crossover assignment|
|Masking||single blind (outcomes assessor)|
|Primary purpose||basic science|
24hr excretion of bioactive compounds
time frame: 24h
Male or female participants at least 18 years old.
- Men and women
- ≥ 18 years old
- Successful biochemical, haematological and urinalysis assessment at screening
- 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.
|Official title||Optimising Vegetable Based Convenience Food Production to Retain Compounds Found in Vegetables|
|Principal investigator||Aedin Cassidy, PhD|
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