VasodilationEarly Phase 1NCT02292342

An Investigation of the Dose-dependent Vascualr Effects of (-)-Epicatechin in Healthy Men

A Early Phase 1 study testing Water, Epicatechin 0.1 mg/kg and Epicatechin 0.5 mg/kg in people with Vasodilation, run by University of Reading at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 \& 1.0 mg/kg BW) in healthy men. Read more about this study

Who is it for?: Ages 18 to 40 years, men onlyHealthy volunteers can take part
Conditions the study is for: Vasodilation
What is being tested?: Water, Epicatechin 0.1 mg/kg and Epicatechin 0.5 mg/kg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 21 participants
Where: 1 siteUnited Kingdom
Study dates: May 2014to May 2016
Phase: Early Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

Body Mass Index 20-27.5 kg/m2
Normal blood pressure at screening (< 150/90)
Non-smoker
Non-vegetarian
'Normal - low' chocolate consumer (<2 potions per week)
'Normal - low' coffee/ tea drinker (<3 cups per day)
Regular exercise routine
Signed consent form

Who cannot join

Haemoglobin (anaemia marker) < 125 g/l
Gamma GT (liver enzymes) > 80 IU/l
Cholesterol > 6.5 mmol/l
Suffered a myocardial infarction or stroke in the last 12 months
Suffers from any cardiovascular or metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
Suffers from any blood-clotting disorder, and/or takes supporting medication

Show all 9Show fewer

Any dietary restrictions or on a weight reducing diet
On any lipid-modifying or blood pressure lowering medication
Consuming any specific vitamin/ herbal supplements or fish oils

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Department of Food and Nutritional Sciences
Reading, Berkshire, RG6 6AP

Other trials in United Kingdom

About this study

Official title: An Acute, Double-blind, Randomised, Placebo-controlled, Crossover Intervention Trial Investigating the Dose-dependent Vascular Effects of Pure (-)-Epicatechin (≤1 mg/kg BW) in Healthy Men.

Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 \& 1.0 mg/kg BW) in healthy men.

Conditions: Vasodilation
Being tested: Water, Epicatechin 0.1 mg/kg, Epicatechin 0.5 mg/kg, Epicatechin 1.0 mg/kg
Keywords: Flow mediated dilatation
Medical subject headings: Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

WaterDietary supplement
Control
Epicatechin 0.1 mg/kgDietary supplement
EC 0.1 mg/kg
Epicatechin 0.5 mg/kgDietary supplement
EC 0.5
Epicatechin 1.0 mg/kgDietary supplement
EC 1.0

Study groups in NCT02292342
Study group	Role	What they receive
0.1 mg/ kg BW pure (-)-epicatechin	Active comparator	0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water. Receives: Dietary Supplement: Water; Dietary Supplement: Epicatechin 0.1 mg/kg; Dietary Supplement: Epicatechin 0.5 mg/kg; Dietary Supplement: Epicatechin 1.0 mg/kg
0.5 mg/ kg BW pure (-)-epicatechin	Active comparator	0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water. Receives: Dietary Supplement: Water; Dietary Supplement: Epicatechin 0.1 mg/kg; Dietary Supplement: Epicatechin 0.5 mg/kg; Dietary Supplement: Epicatechin 1.0 mg/kg
1.0 mg/ kg BW pure (-)-epicatechin	Active comparator	1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water. Receives: Dietary Supplement: Water; Dietary Supplement: Epicatechin 0.1 mg/kg; Dietary Supplement: Epicatechin 0.5 mg/kg; Dietary Supplement: Epicatechin 1.0 mg/kg
0.0 mg/ kg BW pure (-)-epicatechin	Placebo comparator	Water only (3 ml/kg BW) Receives: Dietary Supplement: Water; Dietary Supplement: Epicatechin 0.1 mg/kg; Dietary Supplement: Epicatechin 0.5 mg/kg; Dietary Supplement: Epicatechin 1.0 mg/kg

What is being measured

The primary outcome is the main question the study is designed to answer.

Flow mediated dilatation
Measured: baseline to 2h

Secondary outcomes (3)

Laser Doppler Imaging with Iontophoresis
Measured: baseline to 2h
Plasma (-)-epicatechin metabolites
Measured: baseline to 24h
Plasma nitrate/nitrite
Measured: baseline to 2h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2014May 2016

First posted17 Nov 2014 (estimated)
Study startMay 2014
Primary completionFeb 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for VasodilationStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Early Phase 1
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02292342
Sponsor's protocol ID: EpicatechinStudy
Status last verified: May 2016
First submitted: 23 Oct 2014
Last updated: 30 May 2016
Results posted: No
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingEarly Phase 1
Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
Endothelial Function
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
RecruitingEarly Phase 1
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia
Aging, Menopause
RecruitingPhase 2
The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults
Frailty, Mild Cognitive Impairment
RecruitingEarly Phase 1
Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
Obesity, Vasodilation

All Vasodilation trials

Study at a glance

From the registry record, last updated by the sponsor on 30 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Acute, Double-blind, Randomised, Placebo-controlled, Crossover Intervention Trial Investigating the Dose-dependent Vascular Effects of Pure (-)-Epicatechin (≤1 mg/kg BW) in Healthy Men.
ClinicalTrials.gov ID: NCT02292342
Acronym / sponsor ID: EpicatechinStudy
Conditions: Vasodilation
Keywords: Flow mediated dilatation
Phase: Early Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University of ReadingUniversity, hospital or other
Study start: May 2014
Primary completion: Feb 2016 (actual)
Study completion: May 2016 (actual)
First posted: 17 Nov 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Aim: To investigate the dose-dependent vascular effect (primarily using FMD) of 3 low-level doses of pure (-)-epicatechin ≤ 1 mg/kg BW (0.1, 0.5 \& 1.0 mg/kg BW) in healthy men.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
0.1 mg/ kg BW pure (-)-epicatechin	Active comparator	Dietary Supplement: Water, Dietary Supplement: Epicatechin 0.1 mg/kg, Dietary Supplement: Epicatechin 0.5 mg/kg, Dietary Supplement: Epicatechin 1.0 mg/kg0.1 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.5 mg/ kg BW pure (-)-epicatechin	Active comparator	Dietary Supplement: Water, Dietary Supplement: Epicatechin 0.1 mg/kg, Dietary Supplement: Epicatechin 0.5 mg/kg, Dietary Supplement: Epicatechin 1.0 mg/kg0.5 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
1.0 mg/ kg BW pure (-)-epicatechin	Active comparator	Dietary Supplement: Water, Dietary Supplement: Epicatechin 0.1 mg/kg, Dietary Supplement: Epicatechin 0.5 mg/kg, Dietary Supplement: Epicatechin 1.0 mg/kg1.0 mg/ kg BW pure (-)-epicatechin (according to volunteer) dissolved in 3 ml/kg BW of water.
0.0 mg/ kg BW pure (-)-epicatechin	Placebo comparator	Dietary Supplement: Water, Dietary Supplement: Epicatechin 0.1 mg/kg, Dietary Supplement: Epicatechin 0.5 mg/kg, Dietary Supplement: Epicatechin 1.0 mg/kgWater only (3 ml/kg BW)

Who may qualify

Ages: 18 to 40 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (8 listed)

Body Mass Index 20-27.5 kg/m2
Normal blood pressure at screening (< 150/90)
Non-smoker
Non-vegetarian
'Normal - low' chocolate consumer (<2 potions per week)

Key exclusion criteria (9 listed)

Haemoglobin (anaemia marker) < 125 g/l
Gamma GT (liver enzymes) > 80 IU/l
Cholesterol > 6.5 mmol/l
Suffered a myocardial infarction or stroke in the last 12 months
Suffers from any cardiovascular or metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
WaterControl	Dietary supplement	0.0 mg/ kg BW pure (-)-epicatechin, 0.1 mg/ kg BW pure (-)-epicatechin, 0.5 mg/ kg BW pure (-)-epicatechin, 1.0 mg/ kg BW pure (-)-epicatechin
Epicatechin 0.1 mg/kgEC 0.1 mg/kg	Dietary supplement	0.0 mg/ kg BW pure (-)-epicatechin, 0.1 mg/ kg BW pure (-)-epicatechin, 0.5 mg/ kg BW pure (-)-epicatechin, 1.0 mg/ kg BW pure (-)-epicatechin
Epicatechin 0.5 mg/kgEC 0.5	Dietary supplement	0.0 mg/ kg BW pure (-)-epicatechin, 0.1 mg/ kg BW pure (-)-epicatechin, 0.5 mg/ kg BW pure (-)-epicatechin, 1.0 mg/ kg BW pure (-)-epicatechin
Epicatechin 1.0 mg/kgEC 1.0	Dietary supplement	0.0 mg/ kg BW pure (-)-epicatechin, 0.1 mg/ kg BW pure (-)-epicatechin, 0.5 mg/ kg BW pure (-)-epicatechin, 1.0 mg/ kg BW pure (-)-epicatechin

Primary outcome

Flow mediated dilatation
Time frame: baseline to 2h

3 secondary outcomes

Laser Doppler Imaging with Iontophoresis
Time frame: baseline to 2h
Plasma (-)-epicatechin metabolites
Time frame: baseline to 24h
Plasma nitrate/nitrite
Time frame: baseline to 2h

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2016.
Individual participant dataSharing planned: No

Related trials for Vasodilation

Active, not recruitingEarly Phase 1
Comparing Approaches to Assess Nitric Oxide-dependent Cutaneous Vasodilation
Endothelial Function
RecruitingPhase 4
DECONGEST-AHF: Vasodilatation or Loop Diuretics in Acute Heart Failure
Pulmonary Edema, Congestive Heart Failure
RecruitingEarly Phase 1
Impact of Early Aging and Menopause on the Vascular Responses to Hypoxia
Aging, Menopause
RecruitingPhase 2
The Mito-Frail Trial: Effects of MitoQ on Vasodilation, Mobility and Cognitive Performance in Frail Older Adults
Frailty, Mild Cognitive Impairment
RecruitingEarly Phase 1
Sex Disparities in Hypoxic Vasodilation and Impact of Obesity
Obesity, Vasodilation

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jeremy Spencer, PhD principal investigator

University of Reading

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Water, Epicatechin 0.1 mg/kg and Epicatechin 0.5 mg/kg in people with Vasodilation, run by University of Reading at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Flow mediated dilatation (time frame: baseline to 2h). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02292342.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2016.