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OpenTrials
Completed

NCT Number: NCT04008693

Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

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.

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Key information

Conditions

Aging Abdominal Obesity Body Weight Cardiovascular Diseases Dyslipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Abdominal Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidade Federal do Rio de Janeiro - Campus Macaé

Macaé, Rio de Janeiro, 27930-560, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Aged Garlic Extract

Dietary Supplement

2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic)

Placebo

Other

800 mg of maltodextrin (four capsules)

Primary outcomes

  1. Near infrared spectroscopy 1

    Time frame: 180 minutes after nutritional intervention

    microvascular endothelial function

  2. High performance liquid chromatography 1

    Time frame: Baseline and 180 minutes after nutritional intervention

    Urinary nitrate concentrations

  3. High performance liquid chromatography 2

    Time frame: Baseline and 180 minutes after nutritional intervention

    Urinary thiosulfate concetrations

  4. Near infrared spectroscopy 2

    Time frame: 180 minutes after nutritional intervention

    muscle oxygenation saturated assessment

Sponsors and collaborators

Lead sponsor

Universidade Federal do Rio de Janeiro

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 5, 2019
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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