The Effects of Alkalised Cocoa on Human Vascular Function | NCT01312584

Studies
The Effects of Alkalised Cocoa on Human Vascular Function

NCT01312584

Sponsor

University of Reading

Status

Completed

Last Update Posted

Mar 10, 2011Estimated

Enrollment

10Actual

Phase

Not Applicable

Conditions

Cardiovascular Disease

Interventions

Processed High-flavanol

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2010

Primary Completion Date

Sep 2010Actual

Completion Date

Sep 2010Actual

First Submitted Date

Mar 9, 2011

First Submission Date that Met QC Criteria

Mar 9, 2011

First Posted Date

Mar 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2011

Last Update Posted Date

Mar 10, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The primary propose of this study is to determine how processing, in particular alkalisation, alters the vascular effects of high-flavanols foods such as cocoa

Detailed Description

A randomised, triple blind, cross-over design human intervention studies will be conducted in 10 healthy human volunteers to test the impact of alkalisation on the absorption, metabolism and vascular reactivity of cocoa flavanols. Participants will be requested to consume a standardised high flavanol-rich cocoa, non-alkalised (1745 mg of flavanols), a low-flavanol cocoa, heavily alkalised (1.3 mg of flavanols) and a flavanol-rich cocoa, medium alkalisation (410 mg of flavanols). The three intervention diets are otherwise matched for macro- and micronutrient content. Vascular measurements will be performed by using Flow Mediated Dilation (FMD), Laser Doppler imaging (LDI) and Digital Volume Pulse (DVP). Blood and urine samples will be taken to measure the concentration of flavonoids from the cocoa drinks and markers of blood vessel function. A number of other biochemical and physiological measures will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non alkalised High Flavanol	Placebo Comparator	Non-alkalised high flavanol cocoa drink containing 1745 mg of total flavanols	Dietary Supplement: Processed High-flavanol
Alkalised high Flavanol	Active Comparator	Alkalised high flavanol cocoa drink (medium alkalisation) containing 410 mg of total flavanols	Dietary Supplement: Processed High-flavanol
Alkalised Low Flavanol	Active Comparator	Alkalised low flavanol cocoa drink (heavily alkalised) containing 1.26 mg of total flavanols	Dietary Supplement: Processed High-flavanol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Processed High-flavanol	Dietary Supplement		Alkalised Low Flavanol Alkalised high Flavanol Non alkalised High Flavanol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
In vivo circulatory effects relative to a non-alkalised high-flavanol cocoa.	Flow Mediated Dilation	change in Flow Mediated Dilation response between baseline and 2h

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male
signed consent form
age of 18-35 years inclusive
BMI between 18.5-30

Exclusion Criteria:

Blood pressure > 150/90 mmHg
Haemoglobin (anaemia marker) < 125 g/l
Gamma GT (liver enzymes) > 80 IU/l
Cholesterol > 6.5 mmol/l
Had suffered a myocardial infarction or stroke in the previous 12 months
Suffers from any reproductive disorder
Suffers from any blood-clotting disorder
Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
Any dietary restrictions or on a weight reducing diet
Drinking more than 21 units per week
On any lipid-modifying medication
On any blood pressure lowering medication
On any medication affecting blood clotting
Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
Regular or vigorous exercise (3 times/week, 20 minutes each session)
Smoking

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jeremy Spencer, PhD	University of Reading	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Reading		Reading	Berkshire		United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D002318	Cardiovascular Diseases

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided