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The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults

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ClinicalTrials.gov Identifier: NCT02521779
Recruitment Status : Completed
First Posted : August 13, 2015
Last Update Posted : August 13, 2015
Sponsor:
Information provided by (Responsible Party):
James Hollis, Iowa State University

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.

Condition or disease Intervention/treatment Phase
Endotoxemia Other: Low-fat Treatment Meal Other: Saturated-fat Treatment Meal Other: N-3 fat Treatment Meal Other: N-6 fat Treatment Meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Dietary Fat Affects Postprandial Serum Endotoxin Concentration in Healthy Adults
Study Start Date : April 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fats

Arm Intervention/treatment
Experimental: Test Meal Saturated Fat
Saturated-fat Treatment Meal
Other: Saturated-fat Treatment Meal
Isocaloric test meal that provided 35% fat with saturated fat (16 g).

Experimental: Test Meal N-6 Fat
N-6 fat Treatment Meal.
Other: N-6 fat Treatment Meal
Isocaloric test meal that provided 35% fat with n-6 (7.4 g).

Experimental: Test Meal N-3 Fat
N-3 fat Treatment Meal.
Other: N-3 fat Treatment Meal
Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg)

Experimental: Test Meal Low-fat
Low-fat Treatment Meal.
Other: Low-fat Treatment Meal
Isocaloric test meal that provided 20% fat.




Primary Outcome Measures :
  1. Serum endotoxin concentration [ Time Frame: Change from baseline every one hour, up to five hours ]

Secondary Outcome Measures :
  1. Serum concentration of biomarkers of inflammation [ Time Frame: Change from baseline every one hour, up to five hours ]
  2. Serum concentration of triglycerides, glucose, and non-esterified fatty acids [ Time Frame: Change from baseline every one hour, up to five hours ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02521779


Locations
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United States, Iowa
Nutrition and Wellness Research Center
Ames, Iowa, United States, 50010
Sponsors and Collaborators
Iowa State University
Investigators
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Principal Investigator: James H Hollis, PhD Iowa State University

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Hollis, Associate Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT02521779     History of Changes
Other Study ID Numbers: 14-020
2014-67017-21778 ( Other Grant/Funding Number: USDA )
First Posted: August 13, 2015    Key Record Dates
Last Update Posted: August 13, 2015
Last Verified: August 2015

Keywords provided by James Hollis, Iowa State University:
Inflammation
Endotoxemia
Lipopolysaccharide
Diet
Fat
Postprandial

Additional relevant MeSH terms:
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Endotoxemia
Bacteremia
Sepsis
Infection
Toxemia
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes