Bioefficacy of Phenolic Acids

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01781559
• Collaborator: (none)
• Enrollment: 14
• Location: 1
• Arms: 3
• Duration (Months): 14
• Patients Per Site Per Month: 1

Study Details

Study Description

Brief Summary

The objective is to demonstrate the effect of phenolic acids on endothelial function.

Condition or Disease	Intervention/Treatment	Phase
Endothelial Dysfunction	Dietary Supplement: phenolic acid	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Effect of Phenolic Acids on the Human Vasculature
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Aug 1, 2013
• Actual Study Completion Date: Dec 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: phenolic acid + maltodextrin phenolic acid + maltodextrin;	Dietary Supplement: phenolic acid; phenolic acid
Placebo Comparator: Maltodextrin Maltodextrin	Dietary Supplement: phenolic acid; phenolic acid
Active Comparator: flavanol + maltodextrin flavanol + maltodextrin	Dietary Supplement: phenolic acid; phenolic acid

Outcome Measures

Primary Outcome Measures

1. Change from predose in percent change of flow-mediated dilatation at 1h compared to control treatment [After 1 hour]

Secondary Outcome Measures

1. Change from predose in blood pressure at 0.5h [After 30 min]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Healthy, Men and women

• Subjects with endothelial dysfunction defined as a basal brachial artery flow-mediated dilatation (FMD) measurement between 3% and 8% at screening

Exclusion Criteria:

• Any food allergy

• Abnormal blood pressure defined as follow: systolic <100 or >160 mmHg and diastolic <50 or >100mmHg

• Pregnancy or lactating women

• Regular consumption of cholesterol-lowering or antihypertensive medication

• Smokers

• Inability to restrain from caffeine/tea and alcohol for 12hrs prior to study visits (intake1 day before screening measurements (and 1 day before each visit)

• Not restrain the intake of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study.

• Excessive alcohol intake defined as > 280 g per week for men and >210g per week for women

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	School of Medicine and Pharmacology - University of WA	Perth		Australia	6000

Sponsors and Collaborators

• Nestlé

Investigators

• Principal Investigator: Kevin Croft, Professor, School of Medicine and Pharmacology - University of WA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT01781559
• Other Study ID Numbers: 11.35.NRC
• First Posted: Feb 1, 2013
• Last Update Posted: Dec 12, 2013
• Last Verified: Dec 1, 2013

Study Results

No Results Posted as of Dec 12, 2013