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出境医 / 临床实验 / Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

Aging, Aged Garlic, Vascular Function and Muscle Oxygenation

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.

Condition or disease Intervention/treatment Phase
Aging Hypertension Dyslipidemias Abdominal Obesity Dietary Supplement: Aged Garlic Extract Other: Placebo Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Aged Garlic on Vascular Function and Muscle Oxygenation Responses in the Elderly
Actual Study Start Date : August 26, 2019
Actual Primary Completion Date : January 30, 2020
Actual Study Completion Date : March 30, 2020
Arms and Interventions
Arm Intervention/treatment
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)
Placebo Comparator: Placebo
Maltodextrin
 Other: Placebo
800 mg of maltodextrin (four capsules)
Outcome Measures
Primary Outcome Measures :
  1. Near infrared spectroscopy 1 [ Time Frame: 180 minutes after nutritional intervention ]
    microvascular endothelial function

  2. High performance liquid chromatography 1 [ Time Frame: Baseline and 180 minutes after nutritional intervention ]
    Urinary nitrate concentrations

  3. High performance liquid chromatography 2 [ Time Frame: Baseline and 180 minutes after nutritional intervention ]
    Urinary thiosulfate concetrations

  4. Near infrared spectroscopy 2 [ Time Frame: 180 minutes after nutritional intervention ]
    muscle oxygenation saturated assessment


Eligibility Criteria
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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;
Contacts and Locations

Locations
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Brazil
Universidade Federal do Rio de Janeiro - Campus Macaé
Macaé, Rio De Janeiro, Brazil, 27930-560
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Study Director: Thiago Alvares Universidade Federal do Rio de Janeiro - Campus Macaé
Principal Investigator: Thiago Alvares Universidade Federal do Rio de Janeiro - Campus Macaé
Tracking Information
First Submitted Date  ICMJE June 19, 2019
First Posted Date  ICMJE July 5, 2019
Last Update Posted Date May 19, 2020
Actual Study Start Date  ICMJE August 26, 2019
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 3, 2019)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Aging, Aged Garlic, Vascular Function and Muscle Oxygenation
Official Title  ICMJE Effect of Aged Garlic on Vascular Function and Muscle Oxygenation Responses in the Elderly
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Aging
  • Hypertension
  • Dyslipidemias
  • Abdominal Obesity
Intervention  ICMJE
  • Dietary Supplement: Aged Garlic Extract
    2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic)
  • Other: Placebo
    800 mg of maltodextrin (four capsules)
Study Arms  ICMJE
  • Active Comparator: Kyolic® Hi-Po Formula - Kyolic
    Aged garlic extract
    Intervention: Dietary Supplement: Aged Garlic Extract
  • Placebo Comparator: Placebo
    Maltodextrin
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2019) 		28
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2020
Actual Primary Completion Date January 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04008693
Other Study ID Numbers  ICMJE 86163618.5.0000.5699
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Thiago Alvares, Universidade Federal do Rio de Janeiro
Study Sponsor  ICMJE Universidade Federal do Rio de Janeiro
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Thiago Alvares Universidade Federal do Rio de Janeiro - Campus Macaé
Principal Investigator: Thiago Alvares Universidade Federal do Rio de Janeiro - Campus Macaé
PRS Account Universidade Federal do Rio de Janeiro
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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