Effects of Cinnamomum Supplementation in Chronic Kidney Disease Patients

NCT06286735 | Not Yet Recruiting DMC

• 1 other identifier: DeniseMafra18
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with chronic kidney disease (CKD) experience many complications related to inflammation and oxidative stress that are closely related to the progression of kidney failure and increased mortality. Furthermore, these patients may have intestinal dysbiosis associated with persistent uremia, generating greater production of uremic toxins arising from the metabolism of intestinal bacteria and also helping to maintain the inflammatory process and oxidative stress. In this context, some nutritional strategies have been proposed as an adjuvant therapeutic alternative to modulate inflammation and improve the antioxidant response of patients with CKD, and even more so to modulate the intestinal microbiota. Based on the consolidated knowledge of the role of nutrients and bioactive compounds on the expression of genes related to inflammation, oxidative stress, and also the modulation of the intestinal microbiota, cinnamon, a member of the Lauraceae family, has been widely used as a spice and traditional herbal medicine for centuries and has indicated beneficial benefits in cardiovascular diseases, obesity, diabetes. The bioactive compounds in cinnamomum, such as cinnamaldehyde, cinnamic acid, and cinnamate, can attenuate oxidative stress, inflammation, hyperglycemia, intestinal dysbiosis, and dyslipidemia, which are common complications in CKD patients. Therefore, the present project proposes a longitudinal clinical trial study that aims to evaluate the effects of cinnamomum on transcription factors and inflammatory markers, oxidative stress and modulation of intestinal health in patients with CKD on hemodialysis.

Conditions

Chronic Kidney Diseases

Keywords

cinnamomum; chronic kidney diseases; Inflammation; Oxidative stress; Gut microbiota; Biochemical markers

Outcome Measures

Primary Outcomes (1)

• Concentration of Nuclear factor kappa B (NF-KB)

  Inflammation transcription factor

  3 months

Study Arms (2)

Intervention

ACTIVE COMPARATOR

60 capsules of 500 mg of powdered cinnamomum bark (cinnamomum verum; 40% polyphenols) each. Participants in this group will be instructed to consume two capsules per day, one after lunch and the other after dinner for 3 months.

Dietary Supplement: cinnamomum

Placebo

PLACEBO COMPARATOR

60 capsules with 500 mg of corn starch each. Participants in this group will be instructed to consume two capsules per day, one after lunch and the other after dinner for 3 months.

Other: Placebo

Interventions

cinnamomum DIETARY_SUPPLEMENT

60 capsules of 500 mg of powdered cinnamomum bark (Cinnamomum verum; 40% polyphenols). Participants in this group will be instructed to consume two capsules per day, one after lunch and one after dinner for 3 months.

Intervention

Placebo OTHER

60 capsules with 500 mg of corn starch per month, until the end of the three months of intervention. Participants in this group will be instructed to consume two capsules per day, one after lunch and the other after dinner for 3 months.

Placebo

Eligibility Criteria

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

You may qualify if:

• patients with CKD undergoing conservative treatment stages G3a-G4
• patient in stage 5 (GFR \< 15 mL/min), undergoing hemodialysis for more than 6 months and having an arteriovenous fistula (AVF) as vascular access.

You may not qualify if:

• pregnant, lactating, smoker patients
• patients using antibiotics in the last 3 months, antioxidant supplements and habitual cinnamon intake
• patients with autoimmune and infectious diseases, cancer, liver disease and AIDS, illiterate people and people with disabilities (visual, hearing)
• patients who are allergic or intolerant to the components of the capsules.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Interventions

camphorin protein, Cinnamomum camphora

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 11, 2024
• First Posted: February 29, 2024
• Study Start: April 22, 2025
• Primary Completion: November 22, 2025
• Study Completion (Estimated): December 22, 2026
• Last Updated: April 3, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share