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The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults

Primary Purpose

Endotoxemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Low-fat Treatment Meal
Saturated-fat Treatment Meal
N-3 fat Treatment Meal
N-6 fat Treatment Meal
Sponsored by
Iowa State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endotoxemia focused on measuring Inflammation, Endotoxemia, Lipopolysaccharide, Diet, Fat, Postprandial

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Aged between 18 and 40 years old;
  • Willingness to eat test meals;
  • Body mass index ≥ 19.9 ±0.8 and ≤ 24.9 ±0.8;
  • Weight stable (< 2 kilogram weight change in the previous 3 months)

Exclusion Criteria:

  • Presence of acute or chronic disease;
  • Use of tobacco products;
  • Consumes more than 21 units of alcohol per week;
  • Use of anti-inflammatory medication;
  • History suggestive of macronutrient malabsorption

Sites / Locations

  • Nutrition and Wellness Research Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Test Meal Saturated Fat

Test Meal N-6 Fat

Test Meal N-3 Fat

Test Meal Low-fat

Arm Description

Saturated-fat Treatment Meal

N-6 fat Treatment Meal.

N-3 fat Treatment Meal.

Low-fat Treatment Meal.

Outcomes

Primary Outcome Measures

Serum endotoxin concentration

Secondary Outcome Measures

Serum concentration of biomarkers of inflammation
Serum concentration of triglycerides, glucose, and non-esterified fatty acids

Full Information

First Posted
July 28, 2015
Last Updated
August 10, 2015
Sponsor
Iowa State University
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1. Study Identification

Unique Protocol Identification Number
NCT02521779
Brief Title
The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults
Official Title
Dietary Fat Affects Postprandial Serum Endotoxin Concentration in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2015
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Iowa State University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study was to determine the effect of different dietary fats (saturated or unsaturated) on postprandial endotoxemia and systemic low grade acute inflammation. The investigators hypothesized that meals rich in saturated or n-6 fatty acids would increase postprandial endotoxemia but meals high in n-3 fatty acids would decrease postprandial endotoxemia.Participants were recruited via email and randomized to treatment meal in this single-blind, cross-over study. Each test session participants reported to the laboratory right away in the morning. An indwelling catheter was inserted into the participant non-dominant arm by a qualified nurse and a baseline blood draw was taken. The participant was then provided with one of four test meals (a porridge-type meal containing a different dietary fat), which they ate in entirety within 15 minutes. The participants remained in the laboratory for the next five and a half hours and were not allowed to consume any food or drink except water. During this time, further blood draws were taken at intervals of one hour for a total of five hours after the consumption of the test meal. Collected blood was processed on-site and the serum fraction collected and tested for endotoxin, inflammatory biomarkers, and metabolites.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endotoxemia
Keywords
Inflammation, Endotoxemia, Lipopolysaccharide, Diet, Fat, Postprandial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test Meal Saturated Fat
Arm Type
Experimental
Arm Description
Saturated-fat Treatment Meal
Arm Title
Test Meal N-6 Fat
Arm Type
Experimental
Arm Description
N-6 fat Treatment Meal.
Arm Title
Test Meal N-3 Fat
Arm Type
Experimental
Arm Description
N-3 fat Treatment Meal.
Arm Title
Test Meal Low-fat
Arm Type
Experimental
Arm Description
Low-fat Treatment Meal.
Intervention Type
Other
Intervention Name(s)
Low-fat Treatment Meal
Intervention Description
Isocaloric test meal that provided 20% fat.
Intervention Type
Other
Intervention Name(s)
Saturated-fat Treatment Meal
Intervention Description
Isocaloric test meal that provided 35% fat with saturated fat (16 g).
Intervention Type
Other
Intervention Name(s)
N-3 fat Treatment Meal
Intervention Description
Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg)
Intervention Type
Other
Intervention Name(s)
N-6 fat Treatment Meal
Intervention Description
Isocaloric test meal that provided 35% fat with n-6 (7.4 g).
Primary Outcome Measure Information:
Title
Serum endotoxin concentration
Time Frame
Change from baseline every one hour, up to five hours
Secondary Outcome Measure Information:
Title
Serum concentration of biomarkers of inflammation
Time Frame
Change from baseline every one hour, up to five hours
Title
Serum concentration of triglycerides, glucose, and non-esterified fatty acids
Time Frame
Change from baseline every one hour, up to five hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Aged between 18 and 40 years old; Willingness to eat test meals; Body mass index ≥ 19.9 ±0.8 and ≤ 24.9 ±0.8; Weight stable (< 2 kilogram weight change in the previous 3 months) Exclusion Criteria: Presence of acute or chronic disease; Use of tobacco products; Consumes more than 21 units of alcohol per week; Use of anti-inflammatory medication; History suggestive of macronutrient malabsorption
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James H Hollis, PhD
Organizational Affiliation
Iowa State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nutrition and Wellness Research Center
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17991637
Citation
Erridge C, Attina T, Spickett CM, Webb DJ. A high-fat meal induces low-grade endotoxemia: evidence of a novel mechanism of postprandial inflammation. Am J Clin Nutr. 2007 Nov;86(5):1286-92. doi: 10.1093/ajcn/86.5.1286.
Results Reference
background
PubMed Identifier
25979502
Citation
Fritsche KL. The science of fatty acids and inflammation. Adv Nutr. 2015 May 15;6(3):293S-301S. doi: 10.3945/an.114.006940. Print 2015 May.
Results Reference
background
PubMed Identifier
23305038
Citation
Mani V, Hollis JH, Gabler NK. Dietary oil composition differentially modulates intestinal endotoxin transport and postprandial endotoxemia. Nutr Metab (Lond). 2013 Jan 10;10(1):6. doi: 10.1186/1743-7075-10-6.
Results Reference
background
PubMed Identifier
27816052
Citation
Lyte JM, Gabler NK, Hollis JH. Postprandial serum endotoxin in healthy humans is modulated by dietary fat in a randomized, controlled, cross-over study. Lipids Health Dis. 2016 Nov 5;15(1):186. doi: 10.1186/s12944-016-0357-6.
Results Reference
derived

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The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults

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