Clinical trial NCT02521779: 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
Overall status: COMPLETED
Phase: NA
Conditions: Endotoxemia
Keywords: Inflammation
Endotoxemia
Lipopolysaccharide
Diet
Fat
Postprandial
Lead sponsor: Iowa State University
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Serum endotoxin concentration
timeFrame: Change from baseline every one hour, up to five hours
Secondary outcomes:
measure: Serum concentration of biomarkers of inflammation
timeFrame: Change from baseline every one hour, up to five hours
measure: Serum concentration of triglycerides, glucose, and non-esterified fatty acids
timeFrame: Change from baseline every one hour, up to five hours
Other outcomes:
Locations:
city: Ames
country: United States
facility: Nutrition and Wellness Research Center
state: Iowa
Study officials:
affiliation: Iowa State University
name: James H Hollis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.