Oat Bran and Plasma Lipid and Fecal Bacteria in Coronary Artery Disease Patients

NCT06747234 | Completed

• 1 other identifier: 43012538
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

The development of atherosclerosis is significantly influenced by the interplay between lipid and inflammatory factors. Endotoxemia, defined as the presence of endotoxins, particularly lipopolysaccharides (LPS) derived from Gram-negative bacteria, in the bloodstream, is closely associated with low-grade inflammation. This chronic, systemic inflammatory response does not reach the severity of acute inflammation but can contribute to the development of atherosclerosis and cardiovascular disease (CVD). Lipopolysaccharide-binding protein (LBP) is a soluble acute-phase protein that binds to bacterial LPS. Elevated levels of LBP have been linked to increased low-grade inflammation, which further exacerbates chronic inflammation and metabolic dysregulation. Dietary fiber, such as oat bran, may have a role in mitigating the effects of endotoxemia and its associated inflammation. Furthermore, dietary fiber could play a role in improving plasma lipid profiles. The present study will investigate the effect of oat bran supplementation on cardiometabolic risk markers, LBP concentrations, selected fecal bacteria, and short-chain fatty acids receptors gene expression in peripheral blood mononuclear cells in patients with coronary artery disease.

Conditions

Coronary Arterial Disease (CAD)

Outcome Measures

Primary Outcomes (3)

• Plasma lipids

  Plasma concentrations of triglyceride, cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol

  At the beginning of the study and two months later

• Plasma inflammatory biomarkers

  Plasma c-reactive protein, Interleukin-6, ICAM-1, and VCAM-1

  At the beginning of the study and two months later

• Plasma lipopolysaccharide-binding protein

  Plasma concentrations of lipopolysaccharide-binding protein

  At the beginning of the study and two months later

Secondary Outcomes (2)

• Fecal bacteria

  At the beginning of the study and two months later

• Expression of GPR43 and GPR109A

  At the beginning of the study and two months later

Study Arms (2)

Oat bran

EXPERIMENTAL

Daily consumption of oat bran along with standard medical treatment

Other: Oat bran group

Control

OTHER

Standard medical treatment

Other: Control (Standard treatment)

Interventions

Oat bran group OTHER

Patients consume 28 grams of oat bran daily for two months in addition to their usual medical treatment.

Oat bran

Control (Standard treatment) OTHER

Patients receive standard medical treatment.

Control

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a history of coronary heart disease who have recently undergone coronary angioplasty

You may not qualify if:

• End-stage renal disease
• Inflammatory bowel syndrome (IBD),
• Recent glucocorticoid or antibiotic treatment,
• Cancer undergoing chemotherapy or radiotherapy,
• Any alteration to the treatment plan, including changes in drug type or surgical intervention

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (2)

Shahid Modaress Hospital

Tehran, Tehran Province, Iran

Location

Shahid Modarres Hospital

Tehran, Tehran Province, Iran

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: May 20, 2025
• Primary Completion: December 18, 2025
• Study Completion: December 24, 2025
• Last Updated: February 24, 2026

Record last verified: 2025-05

Locations

IR (2)