Anti-inflammatory Effects of Fiber

Postprandial Inflammation Clinical Trial

Official title:

To Study the Effect of High Fat High Carbohydrate Meal on Oxidative Load, Inflammatory Mediators and Insulin Resistance in Normal and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781350
• Other study ID #: 1955
• Status: Completed
• Phase: N/A
• First received: April 25, 2016
• Last updated: May 23, 2016
• Start date: November 2010
• Est. completion date: May 2013

Study information

• Verified date: May 2016
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The main objective of this research is to investigate the effect of addition of fiber on the high fat high carbohydrate (HFHC) meal induced inflammation and oxidative stress mechanisms at the molecular level in humans, in vivo. The investigators have previously shown that the intake of one HFHC meal leads to an increase in oxidative stress and inflammation. HFHC meal also induces an increase in the expression of suppressor of cytokine signaling- 3 (SOCS-3) in the mononuclear cells (MNC), which interferes with insulin signal transduction and contributes to the pathogenesis of insulin resistance. In contrast, an American heart association (AHA) meal rich in fruits and fiber does not induce these effects. These observations are important since HFHC meal not only induces oxidative stress and inflammation but also lays the foundations of a potentially greater insulin resistance through the induction of SOCS-3, TLR-4 and TLR-2.

Description:

The main objective of this research is to investigate the effect of high fat high carbohydrate (HFHC) meal on inflammatory mechanisms at the molecular level in humans, in vivo versus HFHC meal plus fiber. HFHC meal includes egg muffin, sausage muffin sandwiches and two hash browns. The Investigators have previously shown that the intake of one HFHC meal leads to an increase in reactive oxygen species (ROS) generation and the expression of p47, the key subunit of NADPH oxidase, with a concomitant increase in intranuclear nuclear factor κB (NFkB) binding. More recently, the investigators have also shown that HFHC meal leads to an increase in plasma endotoxin (lipopolysaccharide, LPS) concentrations along with an increase in the expression of Toll like receptor-4 (TLR-4), the receptor for endotoxin, and TLR-2, the receptor for several products of Gram positive bacteria. In addition, it also causes an increase in lipopolysaccharide binding protein (LBP), the protein which facilitates the binding of LPS to CD14 and TLR-4. Finally, HFHC meal also induces an increase in the expression of suppressor of cytokine signaling- 3 (SOCS-3) in the mononuclear cells (MNC) (1), which interferes with insulin signal transduction and contributes to the pathogenesis of insulin resistance. In contrast, an AHA meal does not induce these effects. These observations are important since HFHC meal not only induces oxidative stress and inflammation but also lays the foundations of (2) a potentially greater response to an inflammatory challenge through the induction of an increase in LPS concentrations and the expression of TLR-4 and TLR-2; and (3) insulin resistance through the induction of SOCS-3, TLR-4 and TLR-2.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age: 18 to 80 years of age

• Subject will be available for duration of the study and willing to comply with all study requirements

• Written and informed consent signed and dated

• Nonsmoker

Exclusion Criteria:

• Coronary artery disease (CAD): documented by history of myocardial infarction, angioplasty/stent placement, angina, exercise EKG positive for ischemia or angiographic evidence of CAD

• Patient on non-steroidal anti-inflammatory drugs or steroids

• Hepatic disease (transaminase > 3 times normal)

• Renal impairment (serum creatinine > 1.5 mg/dl)

• History of drug or alcohol abuse

• Participation in any other concurrent clinical trials

• Use of an investigational agent or therapeutic regimen within 30 days of study

• Pregnancy

• Premenopausal women who are trying to be pregnant

• Anemia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Inflammation
• Postprandial Inflammation

Intervention

Other:
• HFHC meal
900 Cal high fat high carbohydrate fast food meal (HFHC). meal includes egg muffin and sausage muffin sandwiches and two hash browns which contain 88g carbohydrates, 51 g fat (33% saturated) and 34 g protein (carbohydrates 41%, protein 17%, and fat 42%).

Dietary Supplement:
• HFHC MEAL plus Fiber
900 Cal high fat high carbohydrate fast food meal containing egg muffin and sausage muffin sandwiches and two hash browns which contain 88g carbohydrates, 51 g fat (33% saturated) and 34 g protein (carbohydrates 41%, protein 17%, and fat 42%).with FiberOne Original cereal 14 grams (half cup) each before and after the HFHC meal

Locations

Country	Name	City	State
United States	ECMC Ambulatory Center, 3rd Floor	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
University at Buffalo

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	effect of addition of fiber on the relative change of NF-Kappa B	The investigators hypothesize that addition of fiber intake will suppress NF-kappa B after HFHC meal. Therefore, changes in NF-kappa B activity will be compared as percent change form baseline after HFHC meal with or without fiber in lean and obese subjects	Baseline and 1 week	No
Secondary	effect of addition of fiber on Changes in ROS generation.	Changes in Reactive oxygen species (ROS) generation between the 2 visits (HFHC meal with or without fiber) will be compared as percent change from baseline.	Baseline and 1 week	No
Secondary	effect of addition of fiber on Changes in TLR-4 mRNA expression in MNC	Changes in TLR-4 mRNA expression in MNC between the 2 visits (HFHC meal with or without fiber) will be compared as percent change from baseline.	Baseline and 1 week	No
Secondary	effect of addition of fiber on Changes in SOCS-3 mRNA expression in MNC	Changes in SOCS-3 mRNA expression in MNC between the 2 visits (HFHC meal with or without fiber) will be compared as percent change from baseline.	Baseline and 1 week	No
Secondary	effect of addition of fiber on Changes in insulin secretion between the 2 visits (HFHC meal with or without fiber) will be compared as percent change from baseline.	Changes in insulin concentrations between the 2 visits (HFHC meal with or without fiber) will be compared as percent change from baseline.	Baseline and 1 week	No