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Trial record 32 of 167 for:    Curcumin | curcumin

The Curcumin Supplement Effect on Saturation Levels of Muscular Oxygen and Vascular Response in Elderly People

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ClinicalTrials.gov Identifier: NCT04119752
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Thiago Alvares, Universidade Federal do Rio de Janeiro

Brief Summary:

Aging has been associated with reduced bioavailability of nitric oxide(NO) and endotelial dysfunction.Curcumin, a phenolic compound present in the rhizomes of turmeric, possesses cardiovascular protective, anti-inflammatory and antioxidante properties.

The present study is evaluating the effects of ingestion of 10 g of curcumin suplementation(CUR) on endothelial function and muscle oxygen saturation in elderly with cardiometabolic risks.Twenty eight elderly individuals have been submitted to 10 g of curcumin suplementation(CUR) or placebo(PLA) (1g of sucralose). Endothelial function and muscle oxygen saturation have been measured 120 minutes after interventions.


Condition or disease Intervention/treatment Phase
Cardiovascular Risk Factor Dietary Supplement: Curcumin powder Dietary Supplement: Placebo Not Applicable

Detailed Description:

Aging has been associated with reduced bioavailability of nitric oxide(NO) and endotelial dysfunction.

Curcumin, a phenolic compound present in the rhizomes of turmeric, possesses cardiovascular protective, anti-inflammatory and antioxidante properties.

The present study is evaluating the effects of ingestion of 10 g of curcumin suplementation(CUR) on endothelial function and muscle oxygen saturation in the elderly at cardiometabolic risks.

The study is randomized, crossed-over, double blind and controlled by placebo.Twenty-eight volunteers have been recruted for the research. They will perform three visits in vascular dymamic laboratory, that is located at the Federal Universite of Rio de Janeiro , campus Macaé. Basic measures have been performed on the first visit: systolic blood pressure (SBP), diastolic blood pressure (DBP) and heart rate (HR), maximun voluntary contraction(MVC), endothelial function analysis, vascular responsiveness during rest( TOV) and rhytmic handgrip exercise. On second and third visits, after 10 minutes period of quiet in rest , volunteers are submitted (SBP),(DBP) and (HR), MVC, blood and urine samples are drawn at baseline in order to analyse curcumin absorption and verify oxidative stress markers( vitamin C and malondialdehyde).Moreover , volunteers are submitted to 10 g of curcumin suplemetation (CUR) diluted in 400 ml cold water or placebo- (1 g of sucralose) that is offered in white capsules( total of 5 caps) ingested with 400 ml of water. Endothelial function and muscle oxygen saturation have been is measured 120 minutes after intervention.Urine and blood samples have been drawn again 20 minutes after exercise.

Before each visit, participants are instructed to fast 8 hours avoiding ingestion of high nitrate such as ( sausages, cheeses, dark green leaves, beets),polifenols foods ( tea, coffee, grape juice and cocoa) and curcumin based dressings(turmeric, curry, colorau).

Also, participants have been instructed not practice plysical activities and not change food habits during the research period.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Masking Description: Double - Blind
Primary Purpose: Prevention
Official Title: The Curcumin Supplement Effect on Saturation Levels of Muscular Oxygen and Vascular Response in Elderly People
Actual Study Start Date : January 4, 2019
Estimated Primary Completion Date : April 5, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

Arm Intervention/treatment
Active Comparator: Curcumin powder
Curcumin powder - 10g
Dietary Supplement: Curcumin powder
10g of curcumin powder

Placebo Comparator: Placebo ( curcumin depleted)
Placebo- sucralose -1g
Dietary Supplement: Placebo
1g of sucralose




Primary Outcome Measures :
  1. Changes in microvascular reactivity [ Time Frame: Changes from baseline at 120 minutes after nutritional intervention ]
    Microvascular reactivity will be evaluated by using a near-infrared spectroscopy device during a vascular occlusion test.

  2. Changes in muscle oxygen saturation [ Time Frame: Changes from baseline at 120 minutes after nutritional intervention ]
    Muscle oxygen saturation will be evaluated by using a near-infrared spectroscopy device during exercise


Secondary Outcome Measures :
  1. Changes in nitric oxide metabolites (plasma nitrate and nitrite) [ Time Frame: Changes from baseline at 120 minutes after nutritional intervention ]
    Nitric oxide metabolites will be evaluated by plasma nitrate and nitrite by using a high-performance liquid chromatography system.



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Seniors,
  • With two or more risk factors for cardiovascular disease:Dyslipidemia, visceral obesity, hypertension, diabetes mellitus 2 and others.

Exclusion Criteria:

  • Smoking,
  • Use of antioxidant drugs during the experiment period,
  • Allergy to components of curcumin,
  • With previous history of cancer, HIV,
  • Neurodegenerative and osteomioarticular diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04119752


Contacts
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Contact: Thiago Alvares, PhD (21)999896554 gpnutmex.ufrj@gmail.com

Locations
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Brazil
Central Coexistence of the Elderly Recruiting
Macaé, Rio De Janeiro, Brazil
Contact: Cristina Rezende    +5522999341655    cristinarzd@gmail.com   
Sponsors and Collaborators
Universidade Federal do Rio de Janeiro
Investigators
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Principal Investigator: Cristina Rezende UFRJ -Campus Macaé

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Responsible Party: Thiago Alvares, Director, Universidade Federal do Rio de Janeiro
ClinicalTrials.gov Identifier: NCT04119752     History of Changes
Other Study ID Numbers: 97055018.1.0000.5699
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Thiago Alvares, Universidade Federal do Rio de Janeiro:
Curcumin
Endothelial dysfunction
Aging
muscle oxygen saturation
Additional relevant MeSH terms:
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Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action