Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

NCT ID: NCT04008693

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-26

Study Completion Date

2020-03-30

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.

Detailed Description

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Conditions

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Aging Hypertension Dyslipidemias Abdominal Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Kyolic® Hi-Po Formula - Kyolic

Aged garlic extract

Group Type ACTIVE_COMPARATOR

Aged Garlic Extract

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Maltodextrin

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

800 mg of maltodextrin (four capsules)

Interventions

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Aged Garlic Extract

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

800 mg of maltodextrin (four capsules)

Intervention Type OTHER

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;
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidade Federal do Rio de Janeiro

OTHER

Sponsor Role lead

Responsible Party

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Thiago Alvares

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Thiago Alvares

Role: STUDY_DIRECTOR

Universidade Federal do Rio de Janeiro - Campus Macaé

Thiago Alvares

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal do Rio de Janeiro - Campus Macaé

Locations

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Universidade Federal do Rio de Janeiro - Campus Macaé

Macaé, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 35505122 (View on PubMed)

Other Identifiers

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86163618.5.0000.5699

Identifier Type: -

Identifier Source: org_study_id

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