Bioefficacy of Phenolic Acids

Nestlé

Status: Completed

Conditions: Endothelial Dysfunction

Treatments: Dietary Supplement: phenolic acid

Study type: Interventional

Funder types: Industry

Identifiers

NCT01781559

11.35.NRC

Details and patient eligibility

About

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

Enrollment: 14 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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14 participants in 3 patient groups, including a placebo group

phenolic acid + maltodextrin

Experimental group

Description:

phenolic acid + maltodextrin;

Treatment:

Dietary Supplement: phenolic acid

Maltodextrin

Placebo Comparator group

Description:

Maltodextrin

Treatment:

Dietary Supplement: phenolic acid

flavanol + maltodextrin

Active Comparator group

Description:

flavanol + maltodextrin

Treatment:

Dietary Supplement: phenolic acid