Effect of Phenolic Acids on the Human Vasculature

Nestlé

Status: Completed

Conditions: Endothelial Dysfunction

Treatments: Other: 86.6 mg hydrolyzed green coffee extract; Other: 43.3 mg hydrolyzed green coffee extract; Other: Placebo; Other: 173 mg hydrolyzed green coffee extract

Study type: Interventional

Funder types: Industry

Identifiers

NCT03599128

1717NRC

Details and patient eligibility

About

This study evaluates effects of different doses of phenolic acids on healthy volunteers.

Full description

It has been suggested that consumption of food rich in phenolic acids can help to improve vascular health, measured by flow mediated dilation (FMD).

Enrollment: 20 patients

Sex: All

Ages: 45 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or postmenopausal female healthy volunteers aged 45-65 years old
• Willing and able to sign written informed consent prior to trial entry
• Healthy as determined by the medical history and physical examination

Exclusion criteria

• Premenopausal women
• Current smokers
• Abnormal blood pressure as defined as follow: systolic <90 or >140 mmHg and diastolic <60 or >90 mmHg
• Regular consumption of cholesterol-lowering medication
• Regular consumption of antihypertensive medication
• Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
• Any food allergies
• Any intakes of multivitamin-tablets and other supplemental compounds 10 days before the study start and throughout the study
• Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
• Acute or chronic major psychiatric illness or other major illness that in the opinion of the investigator would make the subjects' participation in the study unsafe or prevent them from fully complying with the study procedures
• Body mass index (BMI) outside 18-32 kg/m2 range

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo

Treatment:

Other: Placebo

43.3 mg hydrolyzed green coffee extract

Experimental group

Description:

hydrolyzed green coffee extract as interventions

Treatment:

Other: 43.3 mg hydrolyzed green coffee extract

86.6 mg hydrolyzed green coffee extract

Experimental group

Description:

hydrolyzed green coffee extract as interventions

Treatment:

Other: 86.6 mg hydrolyzed green coffee extract

173 mg hydrolyzed green coffee extract

Experimental group

Description:

hydrolyzed green coffee extract as interventions

Treatment:

Other: 173 mg hydrolyzed green coffee extract