Innovation in Food Production Techniques to Improve Bioactive Content

Bioavailability Clinical Trial

— ENRICH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02231502
• Other study ID #: 14/EE/0070
• Status: Active, not recruiting
• Phase: N/A
• First received: August 27, 2014
• Last updated: November 10, 2014
• Start date: July 2014
• Est. completion date: January 2015

Study information

• Verified date: November 2014
• Source: University of East Anglia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Bioavailability

Intervention

Other:
• Vegetable-based convenience food

• Vegetable meal

Locations

Country	Name	City	State
United Kingdom	Norwich Medical School	Norwich	Norfolk

Sponsors (3)

Lead Sponsor	Collaborator
University of East Anglia	Institute of Food Research, PepsiCo Global R&D

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No