Innovation in Food Production Techniques to Improve Bioactive Content (ENRICH)

University of East Anglia

Status: Unknown

Conditions: Bioavailability

Treatments: Other: Vegetable-based convenience food; Other: Vegetable meal

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02231502

14/EE/0070

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Vegetable-based convenience food

Experimental group

Description:

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.

Treatment:

Other: Vegetable-based convenience food

Vegetable meal

Active Comparator group

Description:

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.

Treatment:

Other: Vegetable meal