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

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.

Study Overview

• Status: Unknown
• Conditions: The Impact of Vitamin c and Epicatechin Upon Antioxidant Capactity
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Vitamin C; Dietary supplement: epicatechin

Detailed Description

The sample size is 10 volunteers. This was based on an estimate of the number of datasets required to ensure that at least some of the datasets show time courses that are suitable for the demonstration. The trial uses a cross-over double-blind placebo-controlled design.

A participant information sheet will be given to the participant to read at least 24 hours prior to the screening. Eligibility of participants will be checked during the screening session. The participant anthropometric measurements (height, weight, body fat) will be taken and a Health Questionnaire will be filled completed.

Inclusion Criteria: Healthy adults, BMI 18.5-30

Exclusion Criteria: 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.

At the screening session, the participant will be informed the relevant details of the study. Specifically they must avoid consumption of fruits, vegetables and whole grain products, coffee and tea, beer and wine for 48 hours before the start of the intervention and 24 hours after it (however cola, 7-up and similar caffeine-containing drinks without any real fruits or herbs are fine). After they have had opportunity to ask any questions regarding the testing procedures, if they are happy to take part, they will be free to ask and sign a consent form.

Antioxidant Intervention Session:

Overall, each volunteer will be randomised to receive three treatments in a crossover design, one with epicatechin containing drink as treatment, one with vitamin C and another without antioxidants as placebo.

The volunteers will avoid consumption of fruits, vegetables and whole grain products, coffee and tea, beer and wine for 48 hours before the intervention and 24 hours after it, and the intervention will be administered after an overnight fast (12 hours). At each test, the volunteer will consume 360ml of drink, with either 60mg vitamin C corresponding to a smoothie, or 80 mg epicatechin corresponding to approx. 56g unsweetened baking chocolate (Bhagwat, 2014) or no antioxidant (placebo) and all containing 13% sugar (providing 50g a mixture of glucose and fructose) and a relevant flavouring.

The optimal timing of samples has been determined using mathematical models of the results from the initial study done for BBC with the help of Professor Gunnar Cedersund (Linköping University). Capillary blood samples will be obtained by finger prick and collected in multivette 600 tubes (600µl per tube). at baseline, 0, 0.5, 1, 1.5, 2, 2.5, 3.5, 5, 6, 8 and 24 hours post dose. Breakfast will be served between 1.5 and 2 hours after consumption of the drink, and lunch after the 3.5-hour sample has been collected.

• Study Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirsten Brandt, PhD; Phone Number: +44 (0) 191 208 5852; Email: Kirsten.brandt@ncl.ac.uk
• Study Contact Backup: Name: Anthony Watson, PhD; Phone Number: +44 (0) 191 208 6619; Email: anthony.watson@ncl.ac.uk

Study Locations

• United Kingdom
  • Tyne and Wear
    • Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE1 7RU
      • Recruiting
      • NU-Food Research Facility
      • Contact: Anthony Watson, PhD; Phone Number: +44 (0) 191 208 6619; Email: anthony.watson@ncl.ac.uk
      • Contact: Wendy Bal, BSc; Phone Number: +44 (0) 191 208 6619; Email: wendy.bal@ncl.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy adults,
• BMI 18.5-30

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 360ml water based drink containing 50g mix of glucose and fructose plus flavouring	Dietary supplement: Placebo; Placebo comparitor
Experimental: Vitamin C; 360ml water based drink containig 60mg vitamin C and 50g mix of glucose and fructose plus flavouring	Dietary supplement: Vitamin C; Active treatment
Experimental: Epicatechin; 360ml water based drink containig 80mg epicatechin and 50g mix of glucose and fructose plus flavouring	Dietary supplement: epicatechin; Active treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Antioxidant capacity of epicatechin and vitamin-C	etermine whether the effect on changes of antioxidant capacity in response to epicatechin and vitamin c is equal	Baseline 0, 0.5, 1, 1.5, 2, 2.5, 3.5, 5, 6, 8 and 24 hours post dose

Collaborators and Investigators

• Sponsor: Newcastle University
• Collaborators: Linkoeping University

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (Anticipated): January 1, 2017
• Study Completion: December 7, 2022

Study Registration Dates

• First Submitted: September 8, 2016
• First Submitted That Met QC Criteria: September 8, 2016
• First Posted (Estimate): September 13, 2016

Study Record Updates

• Last Update Posted (Estimate): September 13, 2016
• Last Update Submitted That Met QC Criteria: September 8, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Antioxidants; Ascorbic Acid
• Other Study ID Numbers: NUHEALTH-KB002-AC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No