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Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

Primary Purpose

Aging, Hypertension, Dyslipidemias

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aged Garlic Extract
Placebo
Sponsored by
Universidade Federal do Rio de Janeiro
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Aging, Aged Garlic, Functional Food, Vascular Function, Muscle oxygenation, Exercise performance

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Universidade Federal do Rio de Janeiro - Campus Macaé

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Kyolic® Hi-Po Formula - Kyolic

Placebo

Arm Description

Aged garlic extract

Maltodextrin

Outcomes

Primary Outcome Measures

Near infrared spectroscopy 1
microvascular endothelial function
High performance liquid chromatography 1
Urinary nitrate concentrations
High performance liquid chromatography 2
Urinary thiosulfate concetrations
Near infrared spectroscopy 2
muscle oxygenation saturated assessment

Secondary Outcome Measures

Full Information

First Posted
June 19, 2019
Last Updated
May 15, 2020
Sponsor
Universidade Federal do Rio de Janeiro
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1. Study Identification

Unique Protocol Identification Number
NCT04008693
Brief Title
Aging, Aged Garlic, Vascular Function and Muscle Oxygenation
Official Title
Effect of Aged Garlic on Vascular Function and Muscle Oxygenation Responses in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
August 26, 2019 (Actual)
Primary Completion Date
January 30, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal do Rio de Janeiro

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Hypertension, Dyslipidemias, Abdominal Obesity
Keywords
Aging, Aged Garlic, Functional Food, Vascular Function, Muscle oxygenation, Exercise performance

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kyolic® Hi-Po Formula - Kyolic
Arm Type
Active Comparator
Arm Description
Aged garlic extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Maltodextrin
Intervention Type
Dietary Supplement
Intervention Name(s)
Aged Garlic Extract
Intervention Description
2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
800 mg of maltodextrin (four capsules)
Primary Outcome Measure Information:
Title
Near infrared spectroscopy 1
Description
microvascular endothelial function
Time Frame
180 minutes after nutritional intervention
Title
High performance liquid chromatography 1
Description
Urinary nitrate concentrations
Time Frame
Baseline and 180 minutes after nutritional intervention
Title
High performance liquid chromatography 2
Description
Urinary thiosulfate concetrations
Time Frame
Baseline and 180 minutes after nutritional intervention
Title
Near infrared spectroscopy 2
Description
muscle oxygenation saturated assessment
Time Frame
180 minutes after nutritional intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thiago Alvares
Organizational Affiliation
Universidade Federal do Rio de Janeiro - Campus Macaé
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Thiago Alvares
Organizational Affiliation
Universidade Federal do Rio de Janeiro - Campus Macaé
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universidade Federal do Rio de Janeiro - Campus Macaé
City
Macaé
State/Province
Rio De Janeiro
ZIP/Postal Code
27930-560
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
35505122
Citation
Leitao R, de Oliveira GV, Rezende C, Volino-Souza M, Mesquita J, de Carvalho LL, Alvares TS. Improved microvascular reactivity after aged garlic extract intake is not mediated by hydrogen sulfide in older adults at risk for cardiovascular disease: a randomized clinical trial. Eur J Nutr. 2022 Oct;61(7):3357-3366. doi: 10.1007/s00394-022-02895-y. Epub 2022 May 4.
Results Reference
derived

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Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

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