Effect of Chlorogenic Acids on the Human Vasculature

N

Nestlé

Status

Completed

Conditions

Endothelial Dysfunction

Treatments

Other: Green coffee extract
Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03520452
1716NRC

Details and patient eligibility

About

This study evaluates effects of different doses of chlorogenic acids on vascular health.

Full description

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

Enrollment

22 patients

Sex

All

Ages

45 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  1. Premenopausal women
  2. Current smokers
  3. Abnormal blood pressure, defined as follow: systolic <90 or >140 mmHg and diastolic <60 or >90 mmHg
  4. Regular consumption of cholesterol-lowering medication
  5. Regular consumption of antihypertensive medication
  6. Regular consumption of any vasoactive medication that cannot be discontinued for at least 4 half-lives before the FMD assessment
  7. Any food allergies
  8. Any intakes of multivitamin-tablets and other supplemental compounds within 10 days of the study start and throughout the study
  9. Inability to refrain from coffee/tea and alcohol consumption for 12 h prior to study visits
  10. 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
  11. Use of medication to treat psychiatric illness (depression) within 3 months prior to the study
  12. Recent significant weight loss or gain (>6% of body weight) in the past 3 months
  13. Body mass index (BMI) outside 18-32 kg/m2 range
  14. Alcohol intake > 280g/week (21-28 glasses per week)

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Quadruple Blind

22 participants in 4 patient groups, including a placebo group

Placebo
Placebo Comparator group
Description:
Placebo
Treatment:
Other: Placebo
302 mg green coffee extract
Experimental group
Description:
Green coffee extract
Treatment:
Other: Green coffee extract
604 mg green coffee extract
Experimental group
Description:
Green coffee extract
Treatment:
Other: Green coffee extract
906 mg green coffee extract
Experimental group
Description:
Green coffee extract
Treatment:
Other: Green coffee extract

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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