Effect of Curcumin on Microvascular Response and Tissue Oxygenation

NCT04119752 | Completed

• 1 other identifier: 97055018.1.0000.5699
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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 supplementation (CUR) on microvascular responsiveness and tissue oxygen saturation in the elderly with cardiometabolic risks.Twenty eight older individuals have been submitted to 10 g of curcumin suplementation (CUR) or placebo (PLA) (sucralose). Microvascular responsiveness and tissue oxygen saturation have been measured 120 minutes after interventions.

Conditions

Cardiovascular Risk Factor

Keywords

Curcumin; Microvascular responsiveness; Aging; Tissue oxygen saturation

Outcome Measures

Primary Outcomes (2)

• Changes in microvascular reactivity

  Microvascular reactivity will be evaluated by using a near-infrared spectroscopy device during a vascular occlusion test.

  Changes from baseline at 120 minutes after nutritional intervention

• Changes in tissue oxygen saturation

  Muscle and cerebral oxygen saturation will be evaluated by using a near-infrared spectroscopy device during exercise

  Changes from baseline at 120 minutes after nutritional intervention

Secondary Outcomes (1)

• Changes in nitric oxide metabolites (plasma nitrate and nitrite)

  Changes from baseline at 120 minutes after nutritional intervention

Study Arms (2)

Curcumin powder

ACTIVE COMPARATOR

Curcumin powder - 10g

Dietary Supplement: Curcumin powder

Placebo ( curcumin depleted)

PLACEBO COMPARATOR

Placebo- sucralose -1g

Dietary Supplement: Placebo

Interventions

Curcumin powder DIETARY_SUPPLEMENT

10g of curcumin powder

Curcumin powder

Placebo DIETARY_SUPPLEMENT

1g of sucralose

Placebo ( curcumin depleted)

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Federal do Rio de Janeiro: lead

Study Sites (1)

Central Coexistence of the Elderly

Macaé, Rio de Janeiro, Brazil

Location

Related Publications (1)

• Rezende C, Oliveira GV, Volino-Souza M, Castro P, Murias JM, Alvares TS. Turmeric root extract supplementation improves pre-frontal cortex oxygenation and blood volume in older males and females: a randomised cross-over, placebo-controlled study. Int J Food Sci Nutr. 2022 Mar;73(2):274-283. doi: 10.1080/09637486.2021.1972411. Epub 2021 Sep 22.

  PMID: 34551650 DERIVED

Study Officials

• Cristina Rezende

  UFRJ -Campus Macaé

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: October 8, 2019
• Study Start: January 4, 2019
• Primary Completion: April 5, 2020
• Study Completion: June 24, 2020
• Last Updated: June 26, 2020

Record last verified: 2020-06

Locations

BR (1)