The Role of Dietary Fat on Postprandial Endotoxemia in Healthy Adults

NCT02521779 | Completed

• 2 other identifiers: 14-0202014-67017-21778
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Endotoxemia

Keywords

Inflammation; Endotoxemia; Lipopolysaccharide; Diet; Fat; Postprandial

Outcome Measures

Primary Outcomes (1)

• Serum endotoxin concentration

  Change from baseline every one hour, up to five hours

Secondary Outcomes (2)

• Serum concentration of biomarkers of inflammation

  Change from baseline every one hour, up to five hours

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

  Change from baseline every one hour, up to five hours

Study Arms (4)

Test Meal Saturated Fat

EXPERIMENTAL

Saturated-fat Treatment Meal

Other: Saturated-fat Treatment Meal

Test Meal N-6 Fat

EXPERIMENTAL

N-6 fat Treatment Meal.

Other: N-6 fat Treatment Meal

Test Meal N-3 Fat

EXPERIMENTAL

N-3 fat Treatment Meal.

Other: N-3 fat Treatment Meal

Test Meal Low-fat

EXPERIMENTAL

Low-fat Treatment Meal.

Other: Low-fat Treatment Meal

Interventions

Low-fat Treatment Meal OTHER

Isocaloric test meal that provided 20% fat.

Test Meal Low-fat

Saturated-fat Treatment Meal OTHER

Isocaloric test meal that provided 35% fat with saturated fat (16 g).

Test Meal Saturated Fat

N-3 fat Treatment Meal OTHER

Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg)

Test Meal N-3 Fat

N-6 fat Treatment Meal OTHER

Isocaloric test meal that provided 35% fat with n-6 (7.4 g).

Test Meal N-6 Fat

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Iowa State University: lead

Study Sites (1)

Nutrition and Wellness Research Center

Ames, Iowa, 50010, United States

Location

Related Publications (4)

• 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.

  PMID: 17991637 BACKGROUND

• 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.

  PMID: 25979502 BACKGROUND

• 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.

  PMID: 23305038 BACKGROUND

• 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.

  PMID: 27816052 DERIVED

MeSH Terms

Conditions

Endotoxemia; Inflammation; Platelet Glycoprotein IV Deficiency

Condition Hierarchy (Ancestors)

Bacteremia; Sepsis; Infections; Toxemia; Systemic Inflammatory Response Syndrome; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James H Hollis, PhD

  Iowa State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: August 13, 2015
• Study Start: April 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: April 1, 2015
• Last Updated: August 13, 2015

Record last verified: 2015-08

Locations

US (1)