Cross-over Double-blind Intervention to Investigate the Effects of Defined Antioxidant-containing Drinks on Time Course of Antioxidant Capacity

NCT02898571 | Unknown

• 1 other identifier: NUHEALTH-KB002-AC
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to measure the differences in antioxidant capacity at different time points after consuming a single dose of antioxidant-containing drink (vitamin C or epicatechin) compared with a control drink in 10 volunteers, and then match the data with the proposed modelling corresponding to either homeostasis or accumulation. Additionally it will also determine whether the effect on changes of antioxidant capacity in response to epicatechin and vitamin c is equal.

Conditions

The Impact of Vitamin c and Epicatechin Upon Antioxidant Capactity

Outcome Measures

Primary Outcomes (1)

• Antioxidant capacity

  measure the differences in antioxidant capacity at different time point after consuming a single dose of antioxidant-containing drink (vitamin C or epicatechin) compared with a control and then match the data with the proposed modelling corresponding to either homoeostasis or accumulation.

  Baseline 0, 0.5, 1, 1.5, 2, 2.5, 3.5, 5, 6, 8 and 24 hours post dose

Secondary Outcomes (1)

• Antioxidant capacity of epicatechin and vitamin-C

  Baseline 0, 0.5, 1, 1.5, 2, 2.5, 3.5, 5, 6, 8 and 24 hours post dose

Study Arms (3)

Placebo

PLACEBO COMPARATOR

360ml water based drink containing 50g mix of glucose and fructose plus flavouring

Dietary Supplement: Placebo

Vitamin C

EXPERIMENTAL

360ml water based drink containig 60mg vitamin C and 50g mix of glucose and fructose plus flavouring

Dietary Supplement: Vitamin C

Epicatechin

EXPERIMENTAL

360ml water based drink containig 80mg epicatechin and 50g mix of glucose and fructose plus flavouring

Dietary Supplement: epicatechin

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo comparitor

Placebo

Vitamin C DIETARY_SUPPLEMENT

Active treatment

Vitamin C

epicatechin DIETARY_SUPPLEMENT

Active treatment

Epicatechin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adults,
• BMI 18.5-30

You may not qualify if:

• Any disease or medication that affects metabolism or digestion, smokers, common cold or other inflammatory illness at the time of bio-sample collection. Any other physical or mental condition that in the judgement of the experimenter would mean that participation in the study would be an undue burden on the volunteer

Sponsors & Collaborators

• Newcastle University: lead
• Linkoeping University: collaborator

Study Sites (1)

NU-Food Research Facility

Newcastle upon Tyne, Tyne and Wear, NE1 7RU, United Kingdom

RECRUITING

MeSH Terms

Interventions

Ascorbic Acid; Catechin

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonoids; Chromones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Kirsten Brandt, PhD

CONTACT

+44 (0) 191 208 5852; Kirsten.brandt@ncl.ac.uk

Anthony Watson, PhD

CONTACT

+44 (0) 191 208 6619; anthony.watson@ncl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: NU-Food Facility Manager

Study Record Dates

• First Submitted: September 8, 2016
• First Posted: September 13, 2016
• Study Start: July 1, 2016
• Primary Completion: January 1, 2017
• Last Updated: September 13, 2016

Record last verified: 2016-09

Locations

GB (1)