N/A
Completed N=10
Anti-inflammatory Effects of the Fiber
Source: ClinicalTrials.gov NCT02868788 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcomePrimary: Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation — 224; 167 percentage of change
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peak Change in From Baseline in Reactive Oxygen Species (ROS) Generation |
224; 167 | — |
| SECONDARY Peak Change in From Baseline in Nuclear Factor-Kappa B (NFkB) Activation |
124; 109 | — |
| SECONDARY Percent Change Toll Like Receptor-4 (TLR-4) Levels |
181; 135 | — |
| SECONDARY Change in Plasma Lipopolysaccharides Level From Baseline. |
124; 128 | — |
Eligibility Criteria
Inclusion Criteria
- Men and women 18 to 80 years of age
- Non-smoker (last cigarette at least one month ago)
- Type 2 diabetes for at least 1 year
- Body mass index > 30 kg/m2
Exclusion Criteria
- Participation in any other concurrent clinical trials
- Pregnancy or premenopausal women who are trying to be pregnant
- Patients who are incompetent to give consent
- Patients on non-steroidal anti-inflammatory drugs or steroids
- Concurrent disease that could disrupt intestinal epithelium and increase permeability to endotoxin, ie Celiac and Crohns disease.
- Hepatic disease (transaminase > 3 times normal)
- Renal impairment (serum creatinine > 1.5 mg/dl)
- History of drug or alcohol abuse
- Use of over the counter or prescribed probiotic supplements.
- Recent or current antibiotic use.
- Coronary artery disease (CAD): documented by history of myocardial infarction, angioplasty/stent placement, angina, exercise EKG positive for ischemia or angiographic evidence of CAD
Data sourced from ClinicalTrials.gov (NCT02868788). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.