Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

Study Overview
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Brief Summary
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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.

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

Conditions
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Aging, Hypertension, Dyslipidemias, Abdominal Obesity

Intervention / Treatment
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* Dietary Supplement: Aged Garlic Extract
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Kyolic® Hi-Po Formula - Kyolic<br>Aged garlic extract | Dietary Supplement: Aged Garlic Extract<br>* 2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic)<br>|
| Placebo Comparator: Placebo<br>Maltodextrin | Other: Placebo<br>* 800 mg of maltodextrin (four capsules)<br>|

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Aged Garlic, Functional Food, Vascular Function, Muscle oxygenation, Exercise performance