NCT02868788

Anti-inflammatory Effects of the Fiber

Completed NA Results posted Last updated 17 October 2024

What this trial tests

NA trial testing dietary fiber in Type 2 Diabetes in 10 participants. Completed in 1 July 2018.

Timeline

14 June 2016

Primary endpoint
1 January 2018

1 July 2018

Quick facts

Lead sponsor	University at Buffalo
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	basic science
Enrollment	10
Start date	14 June 2016
Primary completion	1 January 2018
Estimated completion	1 July 2018
Sites	1 location across United States

Drugs / interventions tested

• dietary fiber
• HFHC meal

Conditions studied

• Type 2 Diabetes — all drugs for Type 2 Diabetes →

Sponsor

University at Buffalo

Who can join

Adults 18 to 80, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation Primary · 5hr

mononuclear cells will be isolated by Ficoll-Hypaque method and ROS will be measured by chemiluminescence as an index of NADPH oxidase activation. Measurment will take place at baseline before the meal intervention and hourly for 5 hrs after the meal. The percent change from baseline at peak effect will be calculated.

Group	Value	95% CI
High Fat High Calorie	224	± 15
High Fat High Calorie Plus Fiber	167	± 13

Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation Secondary · 5hr

Nuclear factor-Kappa B (NFkB) activation will be measured at baseline before the meal and hourly up to 5 hrs and percent change from baseline at peak effect is calculated

Group	Value	95% CI
High Fat High Calorie	124	± 14
High Fat High Calorie Plus Fiber	109	± 8

Percent Change Toll Like Receptor-4 (TLR-4) Levels Secondary · 5hr

Toll Like Receptor-4 will be measured by Western Blots at baseline before meal intake and hourly up to 5 hrs after meal. Percent change from baseline at peak effect is calculated.

Group	Value	95% CI
High Fat High Calorie	181	± 15
High Fat High Calorie Plus Fiber	135	± 12

Change in Plasma Lipopolysaccharides Level From Baseline. Secondary · 5hr

Lipopolysaccharide will be measured by commercially available kit (Cambrex Limulus Amebocyte Lysate kit, Lonza Inc. Walkersville, MD). Measurements will take place at baseline before the meals and hourly for next 5 hrs. Percent change from baseline at peak effect is calculated.

Group	Value	95% CI
High Fat High Calorie	124	± 10
High Fat High Calorie Plus Fiber	128	± 11

Sponsor's own description

This study will help elucidate the mechanism underlying the cardioprotective and anti-diabetes effect of dietary fiber by exploring a comprehensive set of inflammatory and oxidative stress markers, based on a contemporary understanding of this process. In addition, there have been very few studies that explored the immediate change in oxidative stress and incretin secretion after fiber intake. In this study, the investigators will be able assess the short term metabolic impact of dietary fiber at great details. The result will contribute to dietary recommendation or designing of fiber supplementation for prevention/treatment of diabetes, obesity and cardiovascular disease.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Enhancing detection and monitoring of circulating tumor cells: Integrative approaches in liquid biopsy advances.
   Velpula T, Buddolla V. · · 2025 · cited 19× · PMID 40453103 · DOI 10.1016/j.jlb.2025.100297