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

Optimising Vegetable Based Convenience Food Production to Retain Compounds Found in Vegetables

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.

Study Overview

• Status: Unknown
• Conditions: Bioavailability
• Intervention / Treatment: Other: Vegetable-based convenience food; Other: Vegetable meal

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Norfolk
    • Norwich, Norfolk, United Kingdom, NR4 7TJ
      • Norwich Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Vegetable-based convenience food
Active Comparator: 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.	Other: Vegetable meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
24hr excretion of bioactive compounds	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.	24h

Collaborators and Investigators

• Sponsor: University of East Anglia
• Collaborators: PepsiCo Global R&D; Quadram Institute Bioscience

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: September 1, 2014
• First Posted (Estimate): September 4, 2014

Study Record Updates

• Last Update Posted (Estimate): November 11, 2014
• Last Update Submitted That Met QC Criteria: November 10, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Bioavailability in healthy individuals
• Other Study ID Numbers: 14/EE/0070