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Anti-inflammatory Effects of Fiber

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ClinicalTrials.gov Identifier: NCT02781350
Recruitment Status : Completed
First Posted : May 24, 2016
Last Update Posted : May 25, 2016
Sponsor:
Information provided by (Responsible Party):
Paresh Dandona, University at Buffalo

Brief 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.

Condition or disease Intervention/treatment Phase
Postprandial Inflammation Other: HFHC meal Dietary Supplement: HFHC MEAL plus Fiber Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Study Start Date : November 2010
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber

Arm Intervention/treatment
Placebo Comparator: High fat high carbohydrate (HFHC) meal
Subjects will consume a HFHC 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%). 35 ml of blood will be obtained at 1h ,2h,3h and 4 h and 5 ml at 15 min,30 min,45 min,75 min and 90 min . A total of 165 ml (11 tablespoon) blood will be collected.
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%).

Experimental: HFHC meal plus Fiber
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%). Subjects will also receive FiberOne Original cereal 14 grams (half cup) before and after the HFHC meal. 35 ml of blood will be obtained at 1h ,2h,3h and 4 h and 5 ml at 15 min,30 min,45 min,75 min and 90 min . A total of 165 ml (11 tablespoon) blood will be collected.
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




Primary Outcome Measures :
  1. effect of addition of fiber on the relative change of NF-Kappa B [ Time Frame: Baseline and 1 week ]
    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


Secondary Outcome Measures :
  1. effect of addition of fiber on Changes in ROS generation. [ Time Frame: Baseline and 1 week ]
    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.

  2. effect of addition of fiber on Changes in TLR-4 mRNA expression in MNC [ Time Frame: Baseline and 1 week ]
    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.

  3. effect of addition of fiber on Changes in SOCS-3 mRNA expression in MNC [ Time Frame: Baseline and 1 week ]
    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.

  4. 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. [ Time Frame: Baseline and 1 week ]
    Changes in insulin concentrations between the 2 visits (HFHC meal with or without fiber) will be compared as percent change from baseline.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02781350


Locations
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United States, New York
ECMC Ambulatory Center, 3rd Floor
Buffalo, New York, United States, 14215
Sponsors and Collaborators
University at Buffalo

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Responsible Party: Paresh Dandona, SUNY Distinguished Professor, University at Buffalo
ClinicalTrials.gov Identifier: NCT02781350     History of Changes
Other Study ID Numbers: 1955
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: May 25, 2016
Last Verified: May 2016

Keywords provided by Paresh Dandona, University at Buffalo:
high fat diet
insulinogenesis
Fiber
inflammation

Additional relevant MeSH terms:
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Inflammation
Pathologic Processes