Innovation in Food Production Techniques to Improve Bioactive Content

Not Applicable

• Conditions: Bioavailability
• Interventions: Other: Vegetable meal; Other: Vegetable-based convenience food

• Registration Number: NCT02231502
• Lead Sponsor: University of East Anglia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-08-27
• Study First Submitted QC: 2014-09-01
• Study First Posted: 2014-09-04
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-10
• Last Update Posted: 2014-11-11
• Primary Completion: 2014-12
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vegetable meal	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-based convenience food	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.

Primary Outcome Measures

Name	Time	Method
24hr excretion of bioactive compounds	24h	A range of bioactive compounds found in vegetables, and their metabolites, will be assessed in blood and/or urine samples collected over a 24 hour period.

Trial Locations

Locations (1)

Norwich Medical School; 🇬🇧 Norwich, Norfolk, United Kingdom