Innovation in Food Production Techniques to Improve Bioactive Content

NCT02231502 | Unknown

• 1 other identifier: 14/EE/0070
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Bioavailability

Keywords

Bioavailability in healthy individuals

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Vegetable-based convenience food

EXPERIMENTAL

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

Vegetable meal

ACTIVE COMPARATOR

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

Interventions

Vegetable-based convenience food OTHER

Vegetable-based convenience food

Vegetable meal OTHER

Vegetable meal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of East Anglia: lead
• Quadram Institute Bioscience: collaborator
• PepsiCo Global R&D: collaborator

Study Sites (1)

Norwich Medical School

Norwich, Norfolk, NR4 7TJ, United Kingdom

Location

Study Officials

• Aedin Cassidy, PhD

  University of East Anglia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2014
• First Posted: September 4, 2014
• Study Start: July 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 11, 2014

Record last verified: 2014-11

Locations

GB (1)