The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults

Endotoxemia Clinical Trial

Official title:

Dietary Fat Affects Postprandial Serum Endotoxin Concentration in Healthy Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02521779
• Other study ID #: 14-020
• Secondary ID: 2014-67017-21778
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: August 10, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: August 2015
• Source: Iowa State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endotoxemia

Intervention

Other:
• Low-fat Treatment Meal
Isocaloric test meal that provided 20% fat.
• Saturated-fat Treatment Meal
Isocaloric test meal that provided 35% fat with saturated fat (16 g).
• N-3 fat Treatment Meal
Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg)
• N-6 fat Treatment Meal
Isocaloric test meal that provided 35% fat with n-6 (7.4 g).

Locations

Country	Name	City	State
United States	Nutrition and Wellness Research Center	Ames	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Iowa State University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum endotoxin concentration		Change from baseline every one hour, up to five hours	Yes
Secondary	Serum concentration of biomarkers of inflammation		Change from baseline every one hour, up to five hours	Yes
Secondary	Serum concentration of triglycerides, glucose, and non-esterified fatty acids		Change from baseline every one hour, up to five hours	No