Anti-inflammatory Effects of Fiber

NCT02781350 | Completed

• 1 other identifier: 1955
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Postprandial Inflammation

Keywords

high fat diet; insulinogenesis; Fiber; inflammation

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• effect of addition of fiber on Changes in ROS generation.

  Baseline and 1 week

• effect of addition of fiber on Changes in TLR-4 mRNA expression in MNC

  Baseline and 1 week

• effect of addition of fiber on Changes in SOCS-3 mRNA expression in MNC

  Baseline and 1 week

• 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.

  Baseline and 1 week

Study Arms (2)

High fat high carbohydrate (HFHC) meal

PLACEBO COMPARATOR

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

HFHC meal plus Fiber

EXPERIMENTAL

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

Interventions

HFHC meal OTHER

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%).

High fat high carbohydrate (HFHC) meal

HFHC MEAL plus Fiber DIETARY_SUPPLEMENT

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

HFHC meal plus Fiber

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University at Buffalo: lead

Study Sites (1)

ECMC Ambulatory Center, 3rd Floor

Buffalo, New York, 14215, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: SUNY Distinguished Professor

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: May 24, 2016
• Study Start: November 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: May 25, 2016

Record last verified: 2016-05

Locations

US (1)