Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

May 15, 2020 updated by: Thiago Alvares, Universidade Federal do Rio de Janeiro

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Rio De Janeiro
      • Macaé, Rio De Janeiro, Brazil, 27930-560
        • Universidade Federal do Rio de Janeiro - Campus Macaé

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal do Rio de Janeiro

Investigators

  • Study Director: Thiago Alvares, Universidade Federal do Rio de Janeiro - Campus Macaé
  • Principal Investigator: Thiago Alvares, Universidade Federal do Rio de Janeiro - Campus Macaé

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2019

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

March 30, 2020

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 19, 2020

Last Update Submitted That Met QC Criteria

May 15, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 86163618.5.0000.5699

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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