NCT04008693

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 26, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

5 months

First QC Date

June 19, 2019

Last Update Submit

May 15, 2020

Conditions

AgingHypertensionDyslipidemiasAbdominal Obesity

Keywords

AgingAged GarlicFunctional FoodVascular FunctionMuscle oxygenationExercise performance

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Kyolic® Hi-Po Formula - Kyolic

ACTIVE COMPARATOR

Aged garlic extract

Dietary Supplement: Aged Garlic Extract

Placebo

PLACEBO COMPARATOR

Maltodextrin

Other: Placebo

Interventions

Aged Garlic ExtractDIETARY_SUPPLEMENT

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

Kyolic® Hi-Po Formula - Kyolic
PlaceboOTHER

800 mg of maltodextrin (four capsules)

Placebo

Eligibility Criteria

Age60 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Cardiometabolic risks
  • Cardiovascular diseases

You may not qualify if:

  • Cancer;
  • HIV positive;
  • Alcohol or drug abuse within the past 6 months previous the visit 1;
  • Garlic allergy;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio de Janeiro - Campus Macaé

Macaé, Rio de Janeiro, 27930-560, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 35505122DERIVED

MeSH Terms

Conditions

HypertensionDyslipidemiasObesity, Abdominal

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesObesityOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thiago Alvares

    Universidade Federal do Rio de Janeiro - Campus Macaé

    STUDY DIRECTOR

  • Thiago Alvares

    Universidade Federal do Rio de Janeiro - Campus Macaé

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 19, 2019

First Posted

July 5, 2019

Study Start

August 26, 2019

Primary Completion

January 30, 2020

Study Completion

March 30, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

BR(1)