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NCT04008693 Clinical Trial

Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

Hypertension Clinical Trial

Official title:
Effect of Aged Garlic on Vascular Function and Muscle Oxygenation Responses in the Elderly

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04008693
Other study ID # 86163618.5.0000.5699
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 26, 2019
Est. completion date March 30, 2020

Study information
Verified date May 2020
Source Universidade Federal do Rio de Janeiro
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The number of elderly individuals affected by cardiovascular diseases has been increasing in our country. Garlic (Allium sativum) has been associated with decrease of reactive species of oxygen, hypertension, high cholesterol, platelet aggregation, blood coagulation and especially cardiovascular diseases. The present study evaluated the effects of a garlic supplementation on vascular function and blood pressure in the elderly at cardiometabolic risk. Twenty-eight elderly individuals were submitted to an ingestion of four capsules of an aged garlic extract (KYOLIC® Aged Garlic Extract™). Muscle oxygenation and function were measured 180 min after interventions. Urinary thiosulfate, blood nitrate, nitrite, systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR) were measured at baseline and 180 min after interventions.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date March 30, 2020
Est. primary completion date January 30, 2020
Accepts healthy volunteers No
Gender All
Age group 60 Years to 90 Years
Eligibility Inclusion Criteria:

- Cardiometabolic risks

- Cardiovascular diseases

Exclusion Criteria:

- Cancer;

- HIV positive;

- Alcohol or drug abuse within the past 6 months previous the visit 1;

- Garlic allergy;

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Aged Garlic Extract
2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic)
Other:
• Placebo
800 mg of maltodextrin (four capsules)

Locations
Country Name City State
Brazil Universidade Federal do Rio de Janeiro - Campus Macaé Macaé Rio De Janeiro

Sponsors (1)
Lead Sponsor Collaborator
Universidade Federal do Rio de Janeiro

Country where clinical trial is conducted

Brazil, 

Outcome
Type Measure Description Time frame Safety issue
Primary Near infrared spectroscopy 1 microvascular endothelial function 180 minutes after nutritional intervention
Primary High performance liquid chromatography 1 Urinary nitrate concentrations Baseline and 180 minutes after nutritional intervention
Primary High performance liquid chromatography 2 Urinary thiosulfate concetrations Baseline and 180 minutes after nutritional intervention
Primary Near infrared spectroscopy 2 muscle oxygenation saturated assessment 180 minutes after nutritional intervention
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