AgingNCT04008693
Aging, Aged Garlic, Vascular Function and Muscle Oxygenation
A study testing Aged Garlic Extract in people with Aging and Hypertension, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Aging, Hypertension, Dyslipidemias
- What is being tested?
- Aged Garlic Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 26 Aug 2019to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cardiometabolic risks
- Cardiovascular diseases
Who cannot join
- Cancer;
- HIV positive;
- Alcohol or drug abuse within the past 6 months previous the visit 1;
- Garlic allergy;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio de Janeiro - Campus Macaé
Macaé, Rio de Janeiro, 27930-560
About this study
Official title: 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.
- Conditions
- Aging, Hypertension, Dyslipidemias, Abdominal Obesity
- Being tested
- Aged Garlic Extract, Placebo
- Keywords
- Aging, Aged Garlic, Functional Food, Vascular Function, Muscle oxygenation, Exercise performance
- Medical subject headings
- Hypertension, Dyslipidemias, Obesity, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aged Garlic ExtractDietary supplement
2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic)
PlaceboOther
800 mg of maltodextrin (four capsules)
| Study group | Role | What they receive |
|---|---|---|
| Kyolic® Hi-Po Formula - Kyolic | Active comparator | Aged garlic extract Receives: Dietary Supplement: Aged Garlic Extract |
| Placebo | Placebo comparator | Maltodextrin Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Near infrared spectroscopy 1
microvascular endothelial function
Measured: 180 minutes after nutritional intervention
High performance liquid chromatography 1
Urinary nitrate concentrations
Measured: Baseline and 180 minutes after nutritional intervention
High performance liquid chromatography 2
Urinary thiosulfate concetrations
Measured: Baseline and 180 minutes after nutritional intervention
Near infrared spectroscopy 2
muscle oxygenation saturated assessment
Measured: 180 minutes after nutritional intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start26 Aug 2019
- Primary completion30 Jan 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thiago Alvares, Universidade Federal do Rio de Janeiro
- Investigators
- Thiago Alvares, Study director, Universidade Federal do Rio de Janeiro - Campus MacaéThiago Alvares, Principal investigator, Universidade Federal do Rio de Janeiro - Campus Macaé
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008693
- Sponsor's protocol ID
- 86163618.5.0000.5699
- Status last verified
- May 2020
- First submitted
- 19 Jun 2019
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35505122
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aged Garlic on Vascular Function and Muscle Oxygenation Responses in the Elderly
- ClinicalTrials.gov ID
- NCT04008693
- Acronym / sponsor ID
- 86163618.5.0000.5699
- Conditions
- Aging, Hypertension, Dyslipidemias, Abdominal Obesity
- Keywords
- Aging, Aged Garlic, Functional Food, Vascular Function, Muscle oxygenation, Exercise performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 26 Aug 2019 (actual)
- Primary completion
- 30 Jan 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kyolic® Hi-Po Formula - Kyolic | Active comparator | Dietary Supplement: Aged Garlic ExtractAged garlic extract |
| Placebo | Placebo comparator | Other: PlaceboMaltodextrin |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Cardiometabolic risks
- Cardiovascular diseases
Key exclusion criteria (4 listed)
- Cancer;
- HIV positive;
- Alcohol or drug abuse within the past 6 months previous the visit 1;
- Garlic allergy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aged Garlic Extract2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic) | Dietary supplement | Kyolic® Hi-Po Formula - Kyolic |
| Placebo800 mg of maltodextrin (four capsules) | Other | Placebo |
Primary outcome
Near infrared spectroscopy 1
Time frame: 180 minutes after nutritional intervention
microvascular endothelial function
High performance liquid chromatography 1
Time frame: Baseline and 180 minutes after nutritional intervention
Urinary nitrate concentrations
High performance liquid chromatography 2
Time frame: Baseline and 180 minutes after nutritional intervention
Urinary thiosulfate concetrations
Near infrared spectroscopy 2
Time frame: 180 minutes after nutritional intervention
muscle oxygenation saturated assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Derived from this study: PubMed 35505122Leitao 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.
Related trials for Aging
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
RecruitingObservational study
Amyloid PET Imaging in the Baltimore Longitudinal Study of Aging
Aging
RecruitingPhase 4
PLLA and CaHA-R for Aesthetic Rejuvenation
Aesthetic
RecruitingObservational study
Genetic and Epigenetic Signatures of Translational Aging Laboratory Testing (GESTALT)
Healthy Volunteers, Non-Healthy/Non-Frail
Recruiting
Exercise for an Aging Liver (EXALIVER)
MASLD - Metabolic Dysfunction-Associated Steatotic Liver Disease, MASH - Metabolic Dysfunction-Associated Steatohepatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thiago Alvares study director
Universidade Federal do Rio de Janeiro - Campus Macaé
Thiago Alvares principal investigator
Universidade Federal do Rio de Janeiro - Campus Macaé
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aged Garlic Extract in people with Aging and Hypertension, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Near infrared spectroscopy 1 (time frame: 180 minutes after nutritional intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04008693, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.