- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02521779
The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults
August 10, 2015 updated by: James Hollis, Iowa State University
Dietary Fat Affects Postprandial Serum Endotoxin Concentration in Healthy Adults
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Ames, Iowa, United States, 50010
- Nutrition and Wellness Research Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Test Meal Saturated Fat
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.
|
Isocaloric test meal that provided 35% fat with n-6 (7.4 g).
|
Experimental: Test Meal N-3 Fat
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.
|
Isocaloric test meal that provided 20% fat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum endotoxin concentration
Time Frame: Change from baseline every one hour, up to five hours
|
Change from baseline every one hour, up to five hours
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Serum concentration of biomarkers of inflammation
Time Frame: Change from baseline every one hour, up to five hours
|
Change from baseline every one hour, up to five hours
|
Serum concentration of triglycerides, glucose, and non-esterified fatty acids
Time Frame: Change from baseline every one hour, up to five hours
|
Change from baseline every one hour, up to five hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James H Hollis, PhD, Iowa State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
July 28, 2015
First Submitted That Met QC Criteria
August 10, 2015
First Posted (Estimate)
August 13, 2015
Study Record Updates
Last Update Posted (Estimate)
August 13, 2015
Last Update Submitted That Met QC Criteria
August 10, 2015
Last Verified
August 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-020
- 2014-67017-21778 (Other Grant/Funding Number: USDA)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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