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
• Status: Completed
• Phase: N/A
• 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
• 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;

Related Conditions & MeSH terms

• Abdominal Obesity
• Aging
• Dyslipidemias
• Hypertension
• Obesity, Abdominal

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